Clinical Trial: IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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 Summary: 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.
Sponsor: University of Pittsburgh

Current Primary Outcome:

• Change from Baseline in Postoperative Pain [ Time Frame: 24 hours ]
  Post operative pain will be assessed at baseline, 4, 8, 12, 16, 20 and 24 hours after surgery. Pain will be self reported by VAS pain scales which range from 0-100mm.
• Narcotic consumption [ Time Frame: 1 week ]
  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.

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Patient satisfaction and mood [ Time Frame: 24 hours ]
  To determine the impact of pain control on satisfaction and mood, subjects will be asked to complete the American Pain Society Patient Outcome Questionnaire (APS-POQ-R) on postoperative day (POD) #1.
• Interference of pain with physical, mental and social activities [ Time Frame: 1 week ]
  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.
• Side effects [ Time Frame: 1 week ]
  Postoperative nausea, pruritus, dizziness and drowsiness will be assessed using the APS-POQ-R questionnaire administered on POD#1. Constipation and time to first bowel movement will be measured with postoperative bowel diaries and the Bristol Stool Scale.

Original Secondary Outcome: Same as current

Information By: University of Pittsburgh

Dates:
Date Received: May 29, 2014
Date Started: July 2014
Date Completion: June 2018
Last Updated: January 27, 2016
Last Verified: January 2016