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Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

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ClinicalTrials.gov Identifier: NCT01075074
Recruitment Status : Completed
First Posted : February 24, 2010
Results First Posted : April 3, 2012
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions Pain
Surgery
Intervention Procedure: Transversus abdominis plane block
Enrollment 75
Recruitment Details Recruited from Prentice Women's Hospital consecutively from 04/01/2010-02/2011
Pre-assignment Details  
Arm/Group Title Ropivacaine 0.05% Normal Saline Ropivacaine 0.25%
Hide Arm/Group Description Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025%
Period Title: Overall Study
Started 25 25 25
Completed 24 23 23
Not Completed 1 2 2
Reason Not Completed
Surgeon changed to open incisional case             1             2             2
Arm/Group Title Ropivacaine 0.05% Normal Saline Ropivacaine 0.25% Total
Hide Arm/Group Description Subjects received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine Subjects received a transversus abdominis plane block using 15 cc of sterile normal saline Subjects received a bilateral transversus abdominis plane block using 15cc of ropivacaine 0.025% Total of all reporting groups
Overall Number of Baseline Participants 25 25 25 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants 25 participants 25 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
25
 100.0%
25
 100.0%
25
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants 25 participants 25 participants 75 participants
38  (8) 38  (10) 35  (9) 37  (9)
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%
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
1.Primary Outcome
Title The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery
Hide Description The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.
Time Frame 24 hours after surgery
Hide Outcome Measure Data
Hide Analysis Population Description
75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.
Arm/Group Title Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Hide Arm/Group Description:
The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Overall Number of Participants Analyzed 24 23 23
Median (Full Range)
Unit of Measure: units on a scale
172
(160 to 190)
157
(148 to 169)
173
(165 to 189)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
Comments A sample size of 23 subjects per group was estimated to achieve 80% power to detect a 10 point difference in the aggregated QOR40 score for the 3 study groups to be compared assuming an overall standard deviation of 12.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments Corrected for 6 comparisons.
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 16
Confidence Interval (2-Sided) 95%
1 to 30
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 17
Confidence Interval (2-Sided) 95%
2 to 31
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 1.0
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1
Confidence Interval (2-Sided) 95%
-16 to 12
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Pain Burden During Early Recovery From Anesthesia
Hide Description Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.
Time Frame Post Operative
Hide Outcome Measure Data
Hide Analysis Population Description
75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.
Arm/Group Title Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Hide Arm/Group Description:
The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
The normal saline group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Overall Number of Participants Analyzed 24 23 23
Median (Inter-Quartile Range)
Unit of Measure: score on a scale * minutes
210
(90 to 345)
405
(360 to 502)
210
(135 to 365)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments P values is corrected for 6 comparisons
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments Corrected for 6 comparisons
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 195
Confidence Interval (2-Sided) 95%
98 to 300
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 195
Confidence Interval (2-Sided) 95%
98 to 278
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-105 to 83
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Opioid Pain Medications Consumed During the First 24 Hours Post Surgery
Hide Description Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.
Arm/Group Title Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Hide Arm/Group Description:
Ropivacaine 0.5% group will receive a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
Normal saline group will receive a bilateral transversus abdominis plane block 15 cc of sterile normal saline.
Ropivicaine 0.25% group will receive a bilateral transversus abdominis plane block using 15 cc of 0.25% ropivacaine on each side
Overall Number of Participants Analyzed 21 23 22
Mean (Full Range)
Unit of Measure: mEq of PO morphine equivalent
40
(13 to 72)
78
(61 to 90)
39
(25 to 58)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Corrected for multiple comparisons (n=6).
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 38
Confidence Interval (2-Sided) 95%
8 to 50
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 40
Confidence Interval (2-Sided) 95%
12 to 47
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 1
Confidence Interval (2-Sided) 95%
-18 to 20
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Time to Hospital Discharge Readiness
Hide Description Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.
Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
75 subjects were randomized in 3 groups of 25, 5 were excluded from analysis because the surgeon had to proceed to an open incision from a laparoscopic case during the procedure.
Arm/Group Title Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Hide Arm/Group Description:
The ropivacaine 0.5% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.5% ropivacaine on each side
The control group will receive a bilateral transversus abdominal plane block using 15 cc of sterile normal saline.
The ropivacaine 0.25% group will receive a bilateral transversus abdominal plane block using 15 cc of 0.25% ropivacaine on each side
Overall Number of Participants Analyzed 24 23 23
Median (Inter-Quartile Range)
Unit of Measure: minutes
90
(75 to 120)
120
(105 to 150)
90
(75 to 135)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.03
Comments Corrected for multiple comparisons (n=6).
Method Kruskal-Wallis
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Normal Saline
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.01
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 30
Confidence Interval (2-Sided) 95%
0 to 60
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Normal Saline, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 30
Confidence Interval (2-Sided) 95%
0 to 60
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Ropivacaine 0.5%, Ropivacaine 0.25%
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Median Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-30 to 30
Estimation Comments [Not Specified]
Time Frame Post anesthesia care unit until discharge
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Hide Arm/Group Description Subjects received a bilateral transversus abdominis plane block using 15 cc of 0.5% ropivacaine Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline. Subjects received a bilateral transversus abdominis plane block using 15cc of ropivicaine 0.25%
All-Cause Mortality
Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/25 (0.00%)      0/25 (0.00%)      0/25 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Ropivacaine 0.5% Normal Saline Ropivacaine 0.25%
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/25 (48.00%)      11/25 (44.00%)      12/25 (48.00%)    
Gastrointestinal disorders       
Nausea  1  12/24 (50.00%)  12 11/23 (47.83%)  11 12/23 (52.17%)  12
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
We did not obtain local anesthetic levels to compare safety profile. We were underpowered to detect a difference in the physical comfort dimension of the QOR questionnaire between the ropivacaine groups and the saline group.
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: Gildasio De Oliveira, MD
Organization: Northwestern University
Phone: 312-926-8373
EMail: g-jr@northwestern.edu
Publications:
Layout table for additonal information
Responsible Party: Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier: NCT01075074    
Other Study ID Numbers: STU00023475
First Submitted: February 23, 2010
First Posted: February 24, 2010
Results First Submitted: March 6, 2012
Results First Posted: April 3, 2012
Last Update Posted: November 21, 2013