MedTrace Logo

Improving Post-Operative Pain and Recovery in Gynecologic Surgery

NCT04175509 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-01-20

Study results available
· View outcomes & findings →

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.

Conditions

  • Postoperative Pain
  • Opioid Use
  • Acetaminophen

Interventions

DRUG

Rectal acetaminophen

Rectal 1300mg

DRUG

Intravenous acetaminophen

Intravenous 1000mg

Sponsors & Collaborators

  • Aultman Health Foundation

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-23
Primary Completion
2021-06-01
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04175509 on ClinicalTrials.gov