IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

204 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2017-08-31

Brief Summary

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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.

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Detailed Description

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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

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

100 cc of normal saline administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

Group Type PLACEBO_COMPARATOR

IV normal saline

Intervention Type DRUG

IV normal saline

IV Acetaminophen

100 cc of Acetaminophen (1000mg/100mL) administered intravenously 10-30 minutes prior to anesthesia induction on the day of surgery.

Group Type EXPERIMENTAL

IV Acetaminophen

Intervention Type DRUG

Interventions

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IV Acetaminophen

Intervention Type DRUG

IV normal saline

Intervention Type DRUG

Other Intervention Names

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Ofirmev placebo

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No