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IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

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ClinicalTrials.gov Identifier: NCT02155738
Recruitment Status : Completed
First Posted : June 4, 2014
Results First Posted : November 19, 2018
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
Halina M Zyczynski, MD, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pelvic Organ Prolapse
Interventions Drug: IV Acetaminophen
Drug: IV normal saline
Enrollment 204
Recruitment Details Women were recruited form the Urogynecology offices of the University of Pittsburgh Medical Center (UPMC) and Allegheny Health Network (AHN) from July 2014 - August 2017.
Pre-assignment Details  
Arm/Group Title Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Hide Arm/Group Description

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent vaginal surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent vaginal surgery.

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent laparoscopic surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent laparoscopic surgery.

Period Title: Overall Study
Started 50 52 51 51
Completed 49 52 51 50
Not Completed 1 0 0 1
Reason Not Completed
Missing critical information             1             0             0             1
Arm/Group Title Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen Total
Hide Arm/Group Description

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent vaginal surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent vaginal surgery.

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent laparoscopic surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent laparoscopic surgery.

Total of all reporting groups
Overall Number of Baseline Participants 49 52 51 50 202
Hide Baseline Analysis Population Description
One subject in the Vaginal Surgery - Placebo group, and one subject in the Laparoscopic Surgery - IV Acetaminophen group did not complete the study. (Missing critical information: (1) information from the pharmacy regarding group assignment; (2) signed informed consent form.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
69.24  (10.87) 70.5  (9.20) 60.22  (8.00) 62.08  (7.00) 65.5  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
Female
49
 100.0%
52
 100.0%
51
 100.0%
50
 100.0%
202
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
African American
1
   2.0%
2
   3.8%
0
   0.0%
1
   2.0%
4
   2.0%
Caucasian
47
  95.9%
50
  96.2%
51
 100.0%
48
  96.0%
196
  97.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
1
   0.5%
Missing
1
   2.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.5%
Postmenopausal  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
43
  87.8%
49
  94.2%
44
  86.3%
45
  90.0%
181
  89.6%
Current Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
3
   6.1%
2
   3.8%
2
   3.9%
1
   2.0%
8
   4.0%
Parity   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Births
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
2
(2 to 3)
2
(2 to 3)
2
(2 to 3)
2
(2 to 3)
2
(2 to 3)
[1]
Measure Description: Parity refers to the number of times the subject gave birth to a baby more than 20 weeks gestation. Parity is expressed as a whole number.
Baseline POPQ Stage   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
Stage II
8
  16.3%
7
  13.5%
8
  15.7%
5
  10.0%
28
  13.9%
Stage III
35
  71.4%
37
  71.2%
42
  82.4%
37
  74.0%
151
  74.8%
Stage IV
5
  10.2%
7
  13.5%
1
   2.0%
8
  16.0%
21
  10.4%
Missing
1
   2.0%
1
   1.9%
0
   0.0%
0
   0.0%
2
   1.0%
[1]
Measure Description: POP-Q Stage is the Pelvic Organ Prolapse Quantification Stage. This is a whole number which refers to the extend of the prolapse, and how far past the hymen it extends. POP-Q Stage is a whole number between 1 and 4. Stage 1 is prolapse which is fully contained within the vagina and above the hymen. Stage 4 is prolapse which extends at least 3 cm beyond the hymen.
Baseline VAS Pain Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 49 participants 52 participants 51 participants 50 participants 202 participants
7.32  (15.73) 3.41  (8.71) 5.57  (15.60) 6.91  (12.75) 5.75  (13.45)
[1]
Measure Description: VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.
1.Primary Outcome
Title Change From Baseline in Postoperative Pain
Hide Description

VAS or Visual Analog Score is a quantitative measure, in this study, of pain that the subject is currently experiencing. The VAS is presented as a straight line which measures 100mm. The subject is instructed to mark an 'X' through this line reflecting the amount of pain that they are currently experiencing. Zero would indicate no pain, while '100' would indicate the most severe pain ever. Thus the total range for this scale would be 0-100 mm. Higher values indicate more pain; lower value indicate less pain.

For this outcome measure, the VAS scores from Baseline and the VAS scores from 24 hours after the end of surgery are being used. The change from baseline in postoperative pain equals the 24 hour VAS score minus the baseline VAS score.

The Change from Baseline would be the 24-hour VAS score minus the Baseline VAS score. Higher values indicate more pain; lower values indicate less pain.

Time Frame 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that a 24 hour VAS was not obtained from the subject.
Arm/Group Title Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Hide Arm/Group Description:

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent vaginal surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent vaginal surgery.

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent laparoscopic surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent laparoscopic surgery.

Overall Number of Participants Analyzed 44 41 41 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
20.5  (23.1) 29.2  (28.3) 20.7  (24.6) 20.1  (25.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaginal Surgery - Placebo, Vaginal Surgery - IV Acetaminophen, Laparoscopic Surgery - Placebo, Laparoscopic Surgery - IV Acetaminophen
Comments Aim 1: Quantify the impact of IV acetaminophen on 1a) postoperative pain scores ... 1a) To achieve this aim, we will measure the degree of postoperative pain using visual analog scales (VAS) at multiple specified time points throughout the postoperative period; we report on change from Baseline VAS at 24 Hours Postop. Null Hypothesis is that there is no difference between subgroups in VAS scores. Sample size was determined considering significant differences in VAS scores.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
2.Primary Outcome
Title Cumulative Narcotic Consumption Over the First 24 Hours
Hide Description Equianalgesic dosage tables will be used to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. Higher numbers indicate higher narcotic usage.
Time Frame First 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Hide Arm/Group Description:

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent vaginal surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent vaginal surgery.

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent laparoscopic surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent laparoscopic surgery.

Overall Number of Participants Analyzed 49 52 51 50
Mean (Standard Deviation)
Unit of Measure: mg
32.5  (24.7) 31.6  (23.6) 47.4  (24.2) 44.5  (24.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Vaginal Surgery - Placebo, Vaginal Surgery - IV Acetaminophen, Laparoscopic Surgery - Placebo, Laparoscopic Surgery - IV Acetaminophen
Comments 1b) We will use equianalgesic dosage tables to convert intra- and postoperative narcotics into morphine equivalents to compare narcotic requirements for the first week after surgery. We hypothesize that those patients receiving preemptive IV acetaminophen will have lower postoperative VAS scores and reduced narcotic requirements compared to placebo.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title Interference of Pain With Physical, Mental and Social Activities
Hide Description

Interference of pain with physical, mental and social activities will be measured by the Patient Reported Outcomes Measures Information Systems-Pain Interference–Short Form 8a (PROMIS PI-SF-8a) administered on POD#7.

This instrument measures the self reported consequences of pain on relevant aspects of one's life. This scale is considered to be universal rather than disease specific. Each question has five response options ranging in value from 1-5. The total raw score for the scale is the sum of all values. The total raw score can range from 8-40. All questions much be answered to obtain a valid score.

A higher PROMIS score indicates more 'hurt' or pain.

Time Frame 1 week
Hide Outcome Measure Data
Hide Analysis Population Description
The number of participants analyzed is less than the total starting the study in each group; data is missing. Missing data indicates that the PROMIS PI-SF-8A was not received from the subject.
Arm/Group Title Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Hide Arm/Group Description:

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent vaginal surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent vaginal surgery.

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent laparoscopic surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent laparoscopic surgery.

Overall Number of Participants Analyzed 41 33 44 40
Mean (Standard Deviation)
Unit of Measure: units on a scale
18.4  (0.15) 22.0  (11.9) 22.9  (8.1) 25.2  (9.4)
Time Frame AEs were collected from day of surgery until 6 weeks postop.
Adverse Event Reporting Description SAEs were defined a priori as readmissions to the hospital for any reason within 6 weeks of surgery. All subject medical records were reviewed to discover these events.
 
Arm/Group Title Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Hide Arm/Group Description

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent vaginal surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent vaginal surgery.

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV normal saline

These subjects underwent laparoscopic surgery.

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

IV Acetaminophen

These subjects underwent laparoscopic surgery.

All-Cause Mortality
Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/49 (0.00%)      0/52 (0.00%)      0/51 (0.00%)      0/50 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/49 (2.04%)      1/52 (1.92%)      0/51 (0.00%)      3/50 (6.00%)    
Surgical and medical procedures         
Readmission within 6 weeks of surgery  [1]  1/49 (2.04%)  1 1/52 (1.92%)  1 0/51 (0.00%)  0 3/50 (6.00%)  3
Indicates events were collected by systematic assessment
[1]
Any readmission within 6 weeks of surgery. Medical records for all subjects were reviewed to discover these events.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Vaginal Surgery - Placebo Vaginal Surgery - IV Acetaminophen Laparoscopic Surgery - Placebo Laparoscopic Surgery - IV Acetaminophen
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/49 (0.00%)      0/52 (0.00%)      0/51 (0.00%)      0/50 (0.00%)    
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: Halina Zyczynski
Organization: University of Pittsburgh
Phone: 412-641-1440
EMail: hzyczynski@mail.magee.edu
Layout table for additonal information
Responsible Party: Halina M Zyczynski, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02155738     History of Changes
Other Study ID Numbers: PFD-C-14-009
First Submitted: May 29, 2014
First Posted: June 4, 2014
Results First Submitted: August 28, 2018
Results First Posted: November 19, 2018
Last Update Posted: November 19, 2018