NCT05300685 Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
| NCT ID | NCT05300685 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | University of California, San Francisco |
| Condition | Urethral Stricture, Male |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 60 participants in total. It began in 2022-02-15 with a primary completion date of 2026-07-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Men, age 18 or older * Undergoing anterior urethroplasty with buccal grafting * Able to consent Exclusion Criteria: * Taking chronic opiates for pain * Diagnosis of chronic pain * Prior buccal urethroplasty * Vulnerable population (e.g. prisoner) * Renal dysfunction or allergy preventing NSAID use * Liver dysfunction or allergy preventing Tylenol use * Medical allergy to local anesthetic * Medical allergy to Peridex/Magic Mouthwash * NYHA Class III/IV * Hematologic condition that excludes patient from surgery * Post-operative complication resulting in inpatient stay * Anesthetic complication * No buccal site surgical complication
Contact & Investigator
Lindsay Hampson, MD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT05300685 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urethral Stricture, Male. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05300685 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 60 participants.
Is NCT05300685 currently recruiting?
Yes, NCT05300685 is actively recruiting participants. Contact the research team at lindsay.hampson@ucsf.edu for enrollment information.
Where is the NCT05300685 trial being conducted?
This trial is being conducted at San Francisco, United States, Washington D.C., United States.
Who is sponsoring the NCT05300685 clinical trial?
NCT05300685 is sponsored by University of California, San Francisco. The principal investigator is Lindsay Hampson, MD at University of California, San Francisco. The trial plans to enroll 60 participants.