Trial Outcomes & Findings for IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair (NCT NCT02155738)
NCT ID: NCT02155738
Last Updated: 2018-11-19
Results Overview
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.
COMPLETED
PHASE4
204 participants
24 hours
2018-11-19
Participant Flow
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.
Participant milestones
| Measure |
Vaginal Surgery - Placebo
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.
|
Vaginal Surgery - IV Acetaminophen
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.
|
Laparoscopic Surgery - Placebo
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.
|
Laparoscopic Surgery - IV Acetaminophen
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 Study
STARTED
|
50
|
52
|
51
|
51
|
|
Overall Study
COMPLETED
|
49
|
52
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Vaginal Surgery - Placebo
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.
|
Vaginal Surgery - IV Acetaminophen
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.
|
Laparoscopic Surgery - Placebo
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.
|
Laparoscopic Surgery - IV Acetaminophen
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 Study
Missing critical information
|
1
|
0
|
0
|
1
|
Baseline Characteristics
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Baseline characteristics by cohort
| Measure |
Vaginal Surgery - Placebo
n=49 Participants
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.
|
Vaginal Surgery - IV Acetaminophen
n=52 Participants
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.
|
Laparoscopic Surgery - Placebo
n=51 Participants
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.
|
Laparoscopic Surgery - IV Acetaminophen
n=50 Participants
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
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
69.24 years
STANDARD_DEVIATION 10.87 • n=5 Participants
|
70.5 years
STANDARD_DEVIATION 9.20 • n=7 Participants
|
60.22 years
STANDARD_DEVIATION 8.00 • n=5 Participants
|
62.08 years
STANDARD_DEVIATION 7.00 • n=4 Participants
|
65.5 years
STANDARD_DEVIATION 9.9 • n=21 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
202 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
47 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
196 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Missing
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Postmenopausal
|
43 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
181 Participants
n=21 Participants
|
|
Current Smoker
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Parity
|
2 births
n=5 Participants
|
2 births
n=7 Participants
|
2 births
n=5 Participants
|
2 births
n=4 Participants
|
2 births
n=21 Participants
|
|
Baseline POPQ Stage
Stage II
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Baseline POPQ Stage
Stage III
|
35 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
151 Participants
n=21 Participants
|
|
Baseline POPQ Stage
Stage IV
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Baseline POPQ Stage
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Baseline VAS Pain Score
|
7.32 units on a scale
STANDARD_DEVIATION 15.73 • n=5 Participants
|
3.41 units on a scale
STANDARD_DEVIATION 8.71 • n=7 Participants
|
5.57 units on a scale
STANDARD_DEVIATION 15.60 • n=5 Participants
|
6.91 units on a scale
STANDARD_DEVIATION 12.75 • n=4 Participants
|
5.75 units on a scale
STANDARD_DEVIATION 13.45 • n=21 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: 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.
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.
Outcome measures
| Measure |
Vaginal Surgery - Placebo
n=44 Participants
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.
|
Vaginal Surgery - IV Acetaminophen
n=41 Participants
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.
|
Laparoscopic Surgery - Placebo
n=41 Participants
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.
|
Laparoscopic Surgery - IV Acetaminophen
n=36 Participants
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.
|
|---|---|---|---|---|
|
Change From Baseline in Postoperative Pain
|
20.5 units on a scale
Standard Deviation 23.1
|
29.2 units on a scale
Standard Deviation 28.3
|
20.7 units on a scale
Standard Deviation 24.6
|
20.1 units on a scale
Standard Deviation 25.7
|
PRIMARY outcome
Timeframe: First 24 hoursEquianalgesic 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.
Outcome measures
| Measure |
Vaginal Surgery - Placebo
n=49 Participants
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.
|
Vaginal Surgery - IV Acetaminophen
n=52 Participants
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.
|
Laparoscopic Surgery - Placebo
n=51 Participants
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.
|
Laparoscopic Surgery - IV Acetaminophen
n=50 Participants
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.
|
|---|---|---|---|---|
|
Cumulative Narcotic Consumption Over the First 24 Hours
|
32.5 mg
Standard Deviation 24.7
|
31.6 mg
Standard Deviation 23.6
|
47.4 mg
Standard Deviation 24.2
|
44.5 mg
Standard Deviation 24.2
|
SECONDARY outcome
Timeframe: 1 weekPopulation: 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.
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.
Outcome measures
| Measure |
Vaginal Surgery - Placebo
n=41 Participants
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.
|
Vaginal Surgery - IV Acetaminophen
n=33 Participants
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.
|
Laparoscopic Surgery - Placebo
n=44 Participants
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.
|
Laparoscopic Surgery - IV Acetaminophen
n=40 Participants
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.
|
|---|---|---|---|---|
|
Interference of Pain With Physical, Mental and Social Activities
|
18.4 units on a scale
Standard Deviation 0.15
|
22.0 units on a scale
Standard Deviation 11.9
|
22.9 units on a scale
Standard Deviation 8.1
|
25.2 units on a scale
Standard Deviation 9.4
|
Adverse Events
Vaginal Surgery - Placebo
Vaginal Surgery - IV Acetaminophen
Laparoscopic Surgery - Placebo
Laparoscopic Surgery - IV Acetaminophen
Serious adverse events
| Measure |
Vaginal Surgery - Placebo
n=49 participants at risk
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.
|
Vaginal Surgery - IV Acetaminophen
n=52 participants at risk
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.
|
Laparoscopic Surgery - Placebo
n=51 participants at risk
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.
|
Laparoscopic Surgery - IV Acetaminophen
n=50 participants at risk
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.
|
|---|---|---|---|---|
|
Surgical and medical procedures
Readmission within 6 weeks of surgery
|
2.0%
1/49 • Number of events 1 • AEs were collected from day of surgery until 6 weeks postop.
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.
|
1.9%
1/52 • Number of events 1 • AEs were collected from day of surgery until 6 weeks postop.
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.
|
0.00%
0/51 • AEs were collected from day of surgery until 6 weeks postop.
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.
|
6.0%
3/50 • Number of events 3 • AEs were collected from day of surgery until 6 weeks postop.
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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place