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NCT03859024 · ClinicalTrials.gov registry record · Phase 4
Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty
A Phase 4 study, sponsored by University of Alabama at Birmingham.
- Completed
- Registry status
- Phase 4
- Development phase
- 48
- Enrollment target
NCT03859024: Completed Phase 4 study, sponsored by University of Alabama at Birmingham.
NCT03859024 is a Phase 4 study that has completed, run by University of Alabama at Birmingham. The registered enrollment target is 48 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03859024, a Phase 4 study, has completed, sponsored by University of Alabama at Birmingham.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 48 participants
- Enrollment target
Study Summary
The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens (enhanced recovery regimen vs standard regimen).
Primary Outcome
Self-report via pain score on the Numerical Rating Scale (NRS) for pain, an 11-point scale for patient self-reporting of pain. A rating of 0 equates to no pain, 1-3 equates to mild pain, 4-6 equates to moderate pain, and 7-10 equates to severe pain. Assessment will occur at clinic visit, at pre-op visit, in pre-op holding before surgery, per anesthesia protocol after surgery in recovery and discharge unit, and at postoperative visit
Interventions
- DRUG Acetaminophen
- DRUG Bupivacaine
- DRUG Oxycodone
- DRUG Gabapentin
- DRUG celebrex
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 48 participants |
| Start Date | 2019-03-22 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 4 |
What the finished NCT03859024 record still lists
NCT03859024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 48 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 5 interventions - of which Acetaminophen is the first listed.
NCT03859024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03859024 about?
NCT03859024 is a clinical study titled "Efficacy of Opioid-limiting Pain Management Protocol in Men Undergoing Urethroplasty". The investigator's study aims to see if an enhanced recovery regimen of pain medications before and during surgery will decrease the use and risk of opioid pain medications as well as improve pain control in anterior urethroplasty patients. Participants will be randomized to one of two pain regimens...
What is the current status of trial NCT03859024?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 48 participants. The study started on 2019-03-22. Estimated completion is 2023-06-30.
What interventions are being tested in trial NCT03859024?
The interventions under investigation include: Acetaminophen (DRUG), Bupivacaine (DRUG), Oxycodone (DRUG), Gabapentin (DRUG), celebrex (DRUG).
Who is sponsoring clinical trial NCT03859024?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03859024's enrollment target sits among peer trials
48 1331st of 2000 higher than 653 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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