Pain control methods after buccal graft urethroplasty
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
This study is testing different ways to manage pain after surgery for men getting a buccal graft urethroplasty to see if a specific pain control method can help reduce discomfort without causing more problems.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 2 sites (San Francisco, California and 1 other locations) |
| Trial ID | NCT05300685 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates different anesthetic protocols for managing oral pain in patients undergoing buccal urethroplasty. It is a blinded, randomized, controlled trial that will compare three established pain management techniques: standard buccal harvest, a basic buccal procedure with a long-acting local anesthetic, and a buccal block. Approximately 60 male subjects aged 18 and older will be enrolled and randomized into one of the three groups to assess the effectiveness of these pain control methods. The study aims to determine if the buccal block can reduce post-operative pain without increasing complications.
Who should consider this trial
Good fit: Ideal candidates for this study are men aged 18 or older who are scheduled to undergo anterior urethroplasty with buccal grafting.
Not a fit: Patients with chronic pain conditions, those on chronic opiates, or individuals with specific medical allergies or complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management strategies for patients undergoing buccal urethroplasty, enhancing their recovery experience.
How similar studies have performed: While various anesthetic techniques have been explored in other contexts, this specific approach to regional pain management in buccal urethroplasty has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 1 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- MedStar Urology — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Lindsay Hampson, MD — University of California, San Francisco
- Study coordinator: Lindsay A Hampson, MD
- Email: lindsay.hampson@ucsf.edu
- Phone: 415-353-2200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.