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NCT04175509 · ClinicalTrials.gov registry record · Phase 4
Improving Post-Operative Pain and Recovery in Gynecologic Surgery
A Phase 4 study, sponsored by Aultman Health Foundation.
- Completed
- Registry status
- Phase 4
- Development phase
- 40
- Enrollment target
NCT04175509: Completed Phase 4 study, sponsored by Aultman Health Foundation.
NCT04175509 is a Phase 4 study that has completed, run by Aultman Health Foundation. The registered enrollment target is 40 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04175509, a Phase 4 study, has completed, sponsored by Aultman Health Foundation.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 40 participants
- Enrollment target
Study 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.
Primary Outcome
Post-operative pain control using a standardized pain scale from 0 (no pain) to 10 (worse pain) measured every 4 hours for the 24 hours, or discharge, whichever comes first. Time points were averaged for each participate and reported as a single value.
Interventions
- DRUG Intravenous acetaminophen
- DRUG Rectal acetaminophen
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-12-23 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 4 |
What the finished NCT04175509 record still lists
NCT04175509 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Intravenous acetaminophen is the first listed.
NCT04175509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04175509 about?
NCT04175509 is a clinical study titled "Improving Post-Operative Pain and Recovery in Gynecologic Surgery". 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 rand...
What is the current status of trial NCT04175509?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 40 participants. The study started on 2019-12-23. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT04175509?
The interventions under investigation include: Intravenous acetaminophen (DRUG), Rectal acetaminophen (DRUG).
Who is sponsoring clinical trial NCT04175509?
This trial is sponsored by Aultman Health Foundation, which has 12 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04175509's enrollment target sits among peer trials
40 1397th of 2000 higher than 533 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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