NCT05300685 · University of California, San Francisco
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
(Buccal)
What this study is about
Patients undergoing buccal urethroplasty will often have significant post-operative taken by mouth 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.
View original scientific description
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.
Interventions
DRUG
Standard Buccal Harvest
Our institutions current anesthetic regimen. Comparison group
DRUG
Basic buccal procedure + Long acting local
Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
DRUG
Basic buccal procedure + Buccal block
Addition of long-acting local anesthetic as a buccal block after oral graft harvest
Primary outcome measures
Change(s) in Post-operative pain
Time frame: Postoperative Day 1, 5, 10
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Francisco, California
- Washington D.C., District of Columbia
Collaborators
MedStar Georgetown University Hospital
Related conditions & keywords
Frequently asked questions
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Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
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Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 5, 2026 · Source of record for eligibility and locations