Overview

Improving Post-Operative Pain and Recovery in Gynecologic Surgery

Status:
Completed
Trial end date:
2021-06-01
Target enrollment:
0
Participant gender:
Female
Summary
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Aultman Health Foundation
Treatments:
Acetaminophen
Criteria
Inclusion Criteria:

- Willing to consent

- Amendable to receive either rectal or intravenous acetaminophen

- Planned hospital stay for at least 24 hours.

Exclusion Criteria:

- 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.