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NCT05300685 · ClinicalTrials.gov registry record · Phase 3
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
A Phase 3 study of Urethral Stricture, Male, sponsored by University of California, San Francisco.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT05300685: Recruiting Phase 3 study of Urethral Stricture, Male, sponsored by University of California, San Francisco.
NCT05300685 is a Phase 3 study of Urethral Stricture, Male that is actively recruiting participants, run by University of California, San Francisco. The registered enrollment target is 60 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05300685, a Phase 3 study of Urethral Stricture, Male, is actively recruiting participants, sponsored by University of California, San Francisco.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no established best practice for peri-operative pain management in this patient population. In addition to traditional post operative pain control, groups have sought various peri-operative anesthetic regimens to improve post operative pain. This has led recently to the description of various regional blocks including buccal and periorbital blocks for peri-operative local anesthetic. No study has looked at superiority of regional pain management in this patient population. This study will aim to assess three established anesthetic protocols for oral pain control in a blinded, randomized controlled trial. Hypothesis: Patients who have buccal block will have lower post op pain without any increase adverse oral outcomes.
Primary Outcome
The Wong-Baker FACES pain scale is a validated scale where a score of 0 is no pain and 10 is the worst pain imaginable. Pain greater than or equal to 5 would result in significant limitations on daily life. Oral, incisional (surgical site), and overall pain will each be assigned a score of 0-10 at each time point (9 total scores).
Conditions Studied
Interventions
- DRUG Standard Buccal Harvest
- DRUG Basic buccal procedure + Long acting local
- DRUG Basic buccal procedure + Buccal block
Study Locations (2)
California
- University of California San Francisco - San Francisco
District of Columbia
- MedStar Urology - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-02-15 |
| Est. Completion | 2026-03-01 |
| Phase | Phase 3 |
What NCT05300685 shows while recruiting
NCT05300685 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Urethral Stricture, Male appearing as the primary indexed condition, and to 3 interventions - of which Standard Buccal Harvest is the first listed.
NCT05300685 reports a single indexed study location in California, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05300685 about?
NCT05300685 is a clinical study titled "Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty". Patients undergoing buccal urethroplasty will often have significant post-operative oral pain from the graft site. Various graft harvest techniques and methods for post-harvest hemostasis including graft site closure have been explored. Despite the frequency of this clinical scenario there is no est...
What is the current status of trial NCT05300685?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2022-02-15. Estimated completion is 2026-03-01.
What conditions does trial NCT05300685 study?
This clinical trial studies the following conditions: Urethral Stricture, Male.
What interventions are being tested in trial NCT05300685?
The interventions under investigation include: Standard Buccal Harvest (DRUG), Basic buccal procedure + Long acting local (DRUG), Basic buccal procedure + Buccal block (DRUG).
Who is sponsoring clinical trial NCT05300685?
This trial is sponsored by University of California, San Francisco, which has 1,713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05300685 being conducted?
This trial has 2 study locations across California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05300685's enrollment target sits among peer trials
60 1805th of 2000 higher than 177 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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