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

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.

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse
• Intervention / Treatment: Drug: IV normal saline; Drug: IV Acetaminophen

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.

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Magee-Womens Hospital of the University of Pittsburgh Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.	Drug: IV normal saline; IV normal saline; Other Names: placebo
Experimental: IV Acetaminophen; 100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.	Drug: IV Acetaminophen; Other Names: Ofirmev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Postoperative Pain	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.	24 hours
Cumulative Narcotic Consumption Over the First 24 Hours	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. Higher numbers indicate higher narcotic usage.	First 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interference of Pain With Physical, Mental and Social Activities	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.	1 week

Collaborators and Investigators

• Sponsor: Halina M Zyczynski, MD

Publications and helpful links

General Publications

• Turner LC, Zyczynski HM, Shepherd JP. Intravenous Acetaminophen Before Pelvic Organ Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2019 Mar;133(3):492-502. doi: 10.1097/AOG.0000000000003102.

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): August 31, 2017
• Study Completion (Actual): August 31, 2017

Study Registration Dates

• First Submitted: May 29, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 4, 2014

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: October 18, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Postoperative pain; IV acetaminophen; Pelvic organ prolapse repair; Pelvic organ prolapse surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Pain, Postoperative; Prolapse; Pelvic Organ Prolapse; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Antipyretics; Acetaminophen
• Other Study ID Numbers: PFD-C-14-009