NCT02155738

IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

The Impact of IV Acetaminophen on Postoperative Pain in Women Undergoing Pelvic Organ Prolapse Repair: A Double-Blind Randomized Placebo Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 204 (actual)
• Sponsor: Halina M Zyczynski, MD · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This randomized controlled trial of IV Acetaminophen compared to placebo will evaluate the effect of preoperative IV Acetaminophen on postoperative pain scores and narcotic requirements in women undergoing surgical repair of pelvic organ prolapse. 204 women will randomly receive 1000 mg of IV Acetaminophen or saline preoperatively within 30 minutes of surgical incision. Subjects will be offered narcotic and non-narcotic pain medications as needed during the postoperative period. Visual analogue pain scales (VAS) will be obtained at 4, 8, 12, 16, 20 and 24 hours postoperatively. Narcotic consumption will be recorded in morphine-equivalents. We hypothesize that women receiving IV Acetaminophen will have lower VAS scores and decreased narcotic requirements compared to controls.

Conditions

• Pelvic Organ Prolapse

Interventions

Type	Name	Description
DRUG	IV Acetaminophen
DRUG	IV normal saline	IV normal saline

Timeline

• Start date: 2014-07-01
• Primary completion: 2017-08-31
• Completion: 2017-08-31
• First posted: 2014-06-04
• Last updated: 2018-11-19
• Results posted: 2018-11-19

Locations

1 site across 1 country: United States