Improving Post-Operative Pain and Recovery in Gynecologic Surgery

Completed · Phase 4

Conditions studied: Postoperative Pain, Opioid Use, Acetaminophen

In brief

This is a clinical investigation to determine the efficacy of rectal versus intravenous acetaminophen in patients undergoing a minimally invasive hysterectomy. All women will receive acetaminophen either rectally or intravenously immediately postoperative, prior to extubation. Patient's will be randomly assigned to either the rectal acetaminophen or the intravenous acetaminophen group. Patient outcomes will be measured through a Numeric Rating Scale (NRS) from 0-10 for pain scores, and total opioid consumption measured in morphine milligram equivalent (MME) for the first 24 hours following surgery, or upon discharge, whichever comes first.

Key facts

Study ID

NCT04175509

Run by

Aultman Health Foundation

People needed

40

Starts

2019-12-23

Expected to finish

2021-06-01

Last updated by the study team

2022-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Willing to consent
• Amendable to receive either rectal or intravenous acetaminophen
• Planned hospital stay for at least 24 hours.

You may not qualify if…

• Patients unable to provide informed consent
• Patients with a history of regular opioid use prior to surgery based on their current home medication list
• Patients who have required regular opioid intake for the 7 days preceding surgery
• Patients with known hypersensitivity to acetaminophen
• Patients with a baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limits
• Unable to complete procedure as planned.

Where it is running

• Aultman Hospital — Canton, Ohio, United States

Full record on ClinicalTrials.gov

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