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Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

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ClinicalTrials.gov Identifier: NCT03040011
Recruitment Status : Completed
First Posted : February 1, 2017
Results First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Collaborator:
Magee-Womens Research Institute
Information provided by (Responsible Party):
Lauren Giugale, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pelvic Organ Prolapse
Surgery
Postoperative Pain
Interventions Drug: Dexamethasone
Drug: Bupivacaine
Procedure: Bilateral Pudendal Nerve Block
Procedure: Bilateral Levator Ani Muscle Injection
Drug: Saline
Enrollment 79
Recruitment Details  
Pre-assignment Details After enrollment but before randomization, 4 patients withdrew from the study: surgical location changed (n=1), declined to participate (n=1), unsafe for general anesthesia (n=1), reported lidocaine allergy (n=1). Because they withdrew prior to randomization, we received permission to enroll an additional 4 patients to meet goal sample size of 75.
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Period Title: Received Randomized Study Intervention
Started 25 25 25
Completed 25 25 25
Not Completed 0 0 0
Period Title: Primary Outcome Follow Up
Started 25 25 25
Completed [1] 21 [2] 24 [3] 24 [3]
Not Completed 4 1 1
[1]
Outcome data are provided for all patients who underwent study intervention by intention to treat.
[2]
Postoperative day one pain score not available for four patients
[3]
Postoperative day one pain score not available for one patient
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm Total
Hide Arm/Group Description

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 75 participants
68.8  (13.6) 68.0  (10.1) 70.2  (9.2) 69.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
Female
25
 100.0%
25
 100.0%
25
 100.0%
75
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
   8.0%
4
  16.0%
0
   0.0%
6
   8.0%
White
22
  88.0%
21
  84.0%
24
  96.0%
67
  89.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   4.0%
0
   0.0%
1
   4.0%
2
   2.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 25 participants 25 participants 25 participants 75 participants
25 25 25 75
Baseline NRS Pain Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 25 participants 75 participants
0
(0 to 0)
0
(0 to 0.3)
0
(0 to 0)
0
(0 to 0)
[1]
Measure Description: Pain measured by the numerical rating scale (NRS) prior to surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Baseline NV Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 25 participants 75 participants
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
[1]
Measure Description: Any preoperative nausea and vomiting was assessed by administering the Postoperative Nausea and Vomiting Intensity Scale prior to surgery. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting. We chose to utilize this scale before and after surgery for consistency.
Baseline AAS Score   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Units on a scale
Number Analyzed 25 participants 25 participants 25 participants 75 participants
94.6
(85.2 to 100)
92.3
(70.6 to 100)
95.5
(81.3 to 100)
94.2
(79.4 to 100.0)
[1]
Measure Description: The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.
Prolapse Procedure  
Measure Type: Count of Participants
Unit of measure:  Participants
Uterosacral Ligament Suspension Number Analyzed 25 participants 25 participants 25 participants 75 participants
4
  16.0%
8
  32.0%
11
  44.0%
23
  30.7%
Sacrospinous Ligament Fixation Number Analyzed 25 participants 25 participants 25 participants 75 participants
2
   8.0%
3
  12.0%
3
  12.0%
8
  10.7%
Colpocleisis Number Analyzed 25 participants 25 participants 25 participants 75 participants
14
  56.0%
9
  36.0%
7
  28.0%
30
  40.0%
Levator Myorrhaphy Number Analyzed 25 participants 25 participants 25 participants 75 participants
5
  20.0%
5
  20.0%
4
  16.0%
14
  18.7%
1.Primary Outcome
Title Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)
Hide Description Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame 24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 21 24 24
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3.0
(1.0 to 5.0)
4.0
(2.0 to 5.0)
3.75
(2.0 to 6.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.39
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title 6 Hour Postoperative Pain Measured by the NRS
Hide Description

Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.

Time Frame 6 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.0
(0.5 to 4.0)
3.0
(2.0 to 4.0)
1.75
(0.6 to 4.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Secondary Outcome
Title POD 2 Postoperative Pain Measured by the NRS
Hide Description Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame 2 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3.0
(1.0 to 5.0)
3.0
(2.0 to 4.0)
4.0
(2.8 to 6.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title POD 3 Postoperative Pain Measured by the NRS
Hide Description Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame 3 days after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
3.0
(2.0 to 5.0)
2.5
(2.0 to 3.3)
3.5
(0.5 to 5.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
5.Secondary Outcome
Title 1 Week Postoperative Pain Measured by the NRS
Hide Description Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.
Time Frame 1 week after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
1.75
(1.0 to 2.75)
2.0
(1.0 to 4.0)
1.0
(0.0 to 3.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.54
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Secondary Outcome
Title Proportion of Patients With Same Day Discharge
Hide Description Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.
Time Frame Day of surgery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
20
  80.0%
22
  88.0%
20
  80.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.80
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
7.Secondary Outcome
Title Postoperative Urinary Retention
Hide Description Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.
Time Frame 0-24 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
13
  52.0%
11
  44.0%
14
  56.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.72
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
8.Secondary Outcome
Title Adverse Events
Hide Description The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.
Time Frame 0-12 weeks postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Number
Unit of Measure: number of adverse events
7 6 9
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.64
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
9.Secondary Outcome
Title Nausea and Vomiting Measured by the PONV Scale
Hide Description Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.
Time Frame 6 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0
(0 to 0)
0
(0 to 0)
0
(0 to 0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.41
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
10.Secondary Outcome
Title Anti-emetic Consumption
Hide Description The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication
Time Frame 3 hours postoperatively
Hide Outcome Measure Data
Hide Analysis Population Description
This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Return to Baseline Activities Using the Activities Assessment Scale
Hide Description

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

Time Frame 1 week postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
11
  44.0%
11
  44.0%
12
  48.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
12.Secondary Outcome
Title Return to Baseline Activities Using the Activities Assessment Scale
Hide Description

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

Time Frame 2 week postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
15
  60.0%
16
  64.0%
14
  56.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
13.Secondary Outcome
Title Return to Baseline Activities Using the Activities Assessment Scale
Hide Description

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

Time Frame 6 weeks postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
19
  76.0%
17
  68.0%
17
  68.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.49
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
14.Secondary Outcome
Title Return to Baseline Activities Using the Activities Assessment Scale
Hide Description

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

Time Frame 12 weeks postoperative
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Measure Type: Count of Participants
Unit of Measure: Participants
21
  84.0%
19
  76.0%
18
  72.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.19
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
15.Secondary Outcome
Title POD 1 Narcotic Consumption
Hide Description The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: oral morphine equivalents
7.5
(0.0 to 15.0)
4.4
(0.0 to 10.0)
7.5
(0.0 to 22.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
16.Secondary Outcome
Title POD 2 Narcotic Consumption
Hide Description The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.
Time Frame Postoperative day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: oral morphine equivalents
7.5
(0.0 to 15.0)
0.0
(0.0 to 11.9)
7.5
(0.0 to 20.6)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.32
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
17.Secondary Outcome
Title POD 3 Narcotic Consumption
Hide Description The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.
Time Frame Postoperative day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: oral morphine equivalents
7.5
(0.0 to 15.0)
0.0
(0.0 to 4.7)
0.0
(0.0 to 18.8)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
18.Secondary Outcome
Title POD 1 Ibuprofen Consumption
Hide Description The total amount of ibuprofen medication used on postoperative day 1.
Time Frame Postoperative day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: milligrams
1200
(0 to 2400)
1200
(750 to 1800)
1200
(0 to 1800)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
19.Secondary Outcome
Title POD 2 Ibuprofen Consumption
Hide Description The total amount of ibuprofen medication used on postoperative day 2.
Time Frame Postoperative day 2
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: milligrams
1200
(0 to 2400)
1200
(750 to 1800)
1800
(300 to 2400)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.40
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
20.Secondary Outcome
Title POD 3 Ibuprofen Consumption
Hide Description The total amount of ibuprofen medication used on postoperative day 3.
Time Frame Postoperative day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description:

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Overall Number of Participants Analyzed 25 25 25
Median (Inter-Quartile Range)
Unit of Measure: milligrams
1200
(0 to 2400)
1200
(0 to 2250)
1800
(150 to 2400)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Bupivacaine/Dexamethasone Arm, Bupivacaine Arm, Placebo Arm
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Time Frame 12 weeks from the date of surgery
Adverse Event Reporting Description Members of the study team including the PI, research staff and coordinator met monthly. Any adverse event that was significant, unexpected and possibly related to the study procedure or medication was reported to the PI, faculty mentor and the IRB within 24 hours. The PI submitted in writing to the IRB a detailed summary of the adverse events for review. After IRB review of the adverse events, a final conclusion and recommendation were provided.
 
Arm/Group Title Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Hide Arm/Group Description

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.

Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.

Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

All-Cause Mortality
Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Serious Adverse Events
Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/25 (4.00%)      0/25 (0.00%)      2/25 (8.00%)    
Injury, poisoning and procedural complications       
Surgical complications  [1]  1/25 (4.00%)  1 0/25 (0.00%)  0 1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders       
Asthma exacerbation  [2]  0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Indicates events were collected by systematic assessment
[1]
Surgical complications not thought to be related to study intervention: ureteral obstruction requiring return to the operating room (n=1) and a case with a rectal injury and sponge miscount, which was resolved prior to the procedure conclusion (n=1)
[2]
Postoperative asthma exacerbation requiring emergency room care
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Bupivacaine/Dexamethasone Arm Bupivacaine Arm Placebo Arm
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/25 (24.00%)      6/25 (24.00%)      7/25 (28.00%)    
Cardiac disorders       
Intraoperative bradycardia  [1]  0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Gastrointestinal disorders       
Nausea and vomiting, diarrhea  [2]  0/25 (0.00%)  0 2/25 (8.00%)  2 0/25 (0.00%)  0
Infections and infestations       
Fever  [3]  1/25 (4.00%)  1 0/25 (0.00%)  0 0/25 (0.00%)  0
Yeast Infection  [4]  0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Wound infection  [5]  0/25 (0.00%)  0 1/25 (4.00%)  1 0/25 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Fall  [6]  0/25 (0.00%)  0 0/25 (0.00%)  0 1/25 (4.00%)  1
Nervous system disorders       
Excess postoperative surgical pain  [7]  1/25 (4.00%)  1 1/25 (4.00%)  1 2/25 (8.00%)  2
Leg numbness  [8]  2/25 (8.00%)  2 1/25 (4.00%)  1 0/25 (0.00%)  0
Renal and urinary disorders       
Urinary tract infection  [9]  2/25 (8.00%)  2 1/25 (4.00%)  1 2/25 (8.00%)  2
Indicates events were collected by systematic assessment
[1]
Bradycardia that required additional medication. Occurred after anesthesia but prior to the start of the surgical procedure. Not thought to be related to study intervention.
[2]
Postoperative nausea and vomiting and diarrhea on that required observation and medication administration. Not thought to be related to study intervention.
[3]
Presented to emergency room with low grade fever of 100.4 Fahrenheit. Complete evaluation with no evidence of infection or other source of fever. No treatment or intervention required. Not thought to be related to study intervention.
[4]
Vulvar yeast infection requiring medication. Not thought to be related to study intervention.
[5]
Postoperative malodorous discharge and fever presumed wound infection (no culture obtained). Treated with antibiotics with symptom resolution. Not thought to be related to study intervention.
[6]
Fell at home one week after surgery requiring evaluation in emergency room. Not thought to be related to study intervention.
[7]
Excessive postoperative surgical site pain that required additional visits and medications
[8]
Transient lower extremity numbness requiring extended observation and ultimately resolved spontaneously
[9]
Postoperative urinary tract infection defined as positive urine culture with symptoms
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Lauren Giugale, PI
Organization: Magee-Womens Hospital of UPMC
Phone: 412-641-1498
EMail: giugalele@upmc.edu
Publications:
Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.
Bupivacaine: Drug Information. UpToDate; 2016.
Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.
Layout table for additonal information
Responsible Party: Lauren Giugale, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03040011    
Other Study ID Numbers: PRO16110378
First Submitted: January 25, 2017
First Posted: February 1, 2017
Results First Submitted: February 7, 2020
Results First Posted: March 9, 2020
Last Update Posted: March 9, 2020