Lindsay C Turner1, Halina M Zyczynski, Jonathan P Shepherd. 1. Division of Urogynecology, Department of Obstetrics and Gynecology, Allegheny Health Network, and the Division of Urogynecology and Pelvic Reconstructive Surgery, Department of Obstetrics, Gynecology, and Reproductive Sciences, University of Pittsburgh, Magee-Womens Research Institute, Pittsburgh, Pennsylvania; and the Department of Obstetrics/Gynecology, Trinity Health of New England, Hartford, Connecticut.
Abstract
OBJECTIVE: To compare the effect of preoperative intravenous (IV) acetaminophen compared with placebo on pain scoresafter pelvic organ prolapse surgery. METHODS: This double-blind placebo-controlled multicenter trial randomized women undergoing prolapse surgery to IVacetaminophen (1,000 mg) or preoperative saline stratified by surgical route (laparoscopic or vaginal). The primary outcome was the change from baseline in patient-reported visual analog scale pain scores at 24 hours after surgery. Secondary outcomes included narcotic use measured in morphine milligram equivalents, satisfaction and quality of life (QOL) using validated questionnaires on postoperative days 1 and 7, and overall side effects. RESULTS:Between 2014 and 2017, 204 women were enrolled and primary-outcome data from 162 were analyzed. Women had a mean (±SD) age of 66±10 years, were predominantly Caucasian (96%) and postmenopausal (96%). Acetaminophen was administered to 52 of the 101 women undergoing vaginal surgery, and 50 of the 101 women undergoinglaparoscopy. There were no overall or route of surgery differences in mean change from baseline pain scores at 24 hours between acetaminophen and placebo (overall 25±26 vs 21±24 mm; vaginal 29±28 vs 21±23 mm; laparoscopic 20±26 vs 21±25 mm). There were no differences in 24-hour morphine milligram equivalent narcotic use (overall 38±25 vs 40±25 mg; vaginal 32±24 vs 33±25 mg; laparoscopic 45±24 vs 47±24 mg). No differences were seen in patient satisfaction, QOL, or side effects, except for urinary retention. CONCLUSION: In women undergoing prolapse repair, preoperative IVacetaminophen did not reduce pain scores or opioid use and had no effect on patient satisfaction or QOL. Routine use of preemptive IV acetaminophen alone is not supported by this study. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02155738.
RCT Entities:
OBJECTIVE: To compare the effect of preoperative intravenous (IV) acetaminophen compared with placebo on pain scores after pelvic organ prolapse surgery. METHODS: This double-blind placebo-controlled multicenter trial randomized women undergoing prolapse surgery to IV acetaminophen (1,000 mg) or preoperative saline stratified by surgical route (laparoscopic or vaginal). The primary outcome was the change from baseline in patient-reported visual analog scale pain scores at 24 hours after surgery. Secondary outcomes included narcotic use measured in morphine milligram equivalents, satisfaction and quality of life (QOL) using validated questionnaires on postoperative days 1 and 7, and overall side effects. RESULTS: Between 2014 and 2017, 204 women were enrolled and primary-outcome data from 162 were analyzed. Women had a mean (±SD) age of 66±10 years, were predominantly Caucasian (96%) and postmenopausal (96%). Acetaminophen was administered to 52 of the 101 women undergoing vaginal surgery, and 50 of the 101 women undergoing laparoscopy. There were no overall or route of surgery differences in mean change from baseline pain scores at 24 hours between acetaminophen and placebo (overall 25±26 vs 21±24 mm; vaginal 29±28 vs 21±23 mm; laparoscopic 20±26 vs 21±25 mm). There were no differences in 24-hour morphine milligram equivalent narcotic use (overall 38±25 vs 40±25 mg; vaginal 32±24 vs 33±25 mg; laparoscopic 45±24 vs 47±24 mg). No differences were seen in patient satisfaction, QOL, or side effects, except for urinary retention. CONCLUSION: In women undergoing prolapse repair, preoperative IV acetaminophen did not reduce pain scores or opioid use and had no effect on patient satisfaction or QOL. Routine use of preemptive IV acetaminophen alone is not supported by this study. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02155738.