IV Acetaminophen for Postoperative Pain After Pelvic Organ Prolapse Repair



Status:Completed
Conditions:Post-Surgical Pain, Women's Studies
Therapuetic Areas:Musculoskeletal, Reproductive
Healthy:No
Age Range:18 - Any
Updated:11/21/2018
Start Date:July 2014
End Date:August 31, 2017

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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.

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.

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
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Lindsay Turner, MD
?
mi
from
Pittsburgh, PA
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