Phase 4
N=204
IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair
Pelvic Organ Prolapse
Bottom Line
View on ClinicalTrials.gov: NCT02155738 ↗Enrolled (actual)
204
Serious AEs
2.5%
Results posted
Nov 2018
Primary outcome: Primary: Change From Baseline in Postoperative Pain — 20.5; 29.2; 20.7; 20.1 units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- IV Acetaminophen (Drug); IV normal saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Halina M Zyczynski, MD
- Primary completion
- Aug 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Postoperative Pain |
20.5; 29.2; 20.7; 20.1 | <0.05 sig |
| PRIMARY Cumulative Narcotic Consumption Over the First 24 Hours |
32.5; 31.6; 47.4; 44.5 | <0.05 sig |
| SECONDARY Interference of Pain With Physical, Mental and Social Activities |
18.4; 22.0; 22.9; 25.2 | — |
Summary
The purpose of this study is to determine whether preoperative IV Acetaminophen reduces postoperative pain and narcotic consumption in women undergoing surgical repair of pelvic organ prolapse.
Eligibility Criteria
Inclusion Criteria
- Women ≥ 18 years of age
- scheduled to undergo surgery for POP via a vaginal or minimally invasive (laparoscopic/robotic) route at the University of Pittsburgh Medical Center
- women anticipated to have a hospital stay ≥24 hours
Exclusion Criteria
- allergy/intolerance to acetaminophen
- hepatic dysfunction
- significant alcohol use - defined as patient reported consumption of more than 7 standard drinks per week and/or 3 drinks per day
Data sourced from ClinicalTrials.gov (NCT02155738). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.