Phase 4
N=40
Improving Post-Operative Pain and Recovery in Gynecologic Surgery
Postoperative Pain · Opioid Use · Acetaminophen
Bottom Line
View on ClinicalTrials.gov: NCT04175509 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Postoperative Pain: Standardized Pain Scale — 2.82; 3.18 score on a scale — p=.378
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rectal acetaminophen (Drug); Intravenous acetaminophen (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Aultman Health Foundation
- Primary completion
- Jun 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Postoperative Pain: Standardized Pain Scale |
2.99; 3.36 | 0.43 |
| SECONDARY Opioid Use |
15.52; 14.17 | 0.77 |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT04175509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.