IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair

Halina M Zyczynski, MD

Status and phase: Completed; Phase 4

Conditions: Pelvic Organ Prolapse

Treatments: Drug: IV normal saline; Drug: IV Acetaminophen

Study type: Interventional

Funder types: Other

Identifiers

NCT02155738

PFD-C-14-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 204 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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204 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: IV normal saline

IV Acetaminophen

Experimental group

Description:

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

Treatment:

Drug: IV Acetaminophen