CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 40 enrolled
Drug / intervention
Rectal acetaminophen +1 moredrug
Likely dose
Rectal acetaminophen 1300mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04175509
NCT04175509Phase 4Completed

Improving Post-Operative Pain and Recovery in Gynecologic Surgery

Aultman Health Foundation·interventional·Posted Nov 25, 2019·Updated Jan 20, 2022

In Brief

A Phase 4 clinical trial evaluating Rectal acetaminophen and Intravenous acetaminophen for Postoperative Pain and 2 related conditions. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 4CompletedFinished
2020202120222023202420252026
First PostedNov 25, 2019
Enrollment StartDec 23, 2019
Primary CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 6.6 years ago

Interventions

Rectal acetaminophendrug

Rectal 1300mg

Intravenous acetaminophendrug

Intravenous 1000mg