NCT05300685

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a blinded, randomized, controlled trial following patients undergoing buccal urethroplasty (see criteria). This study will aim to assess three established anesthetic protocols for oral pain control. Each study arm holds equal weight. Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive the following graft harvest techniques, which are all considered standard of care. Group 1: Current Buccal Harvest * Infiltration of lidocaine 1% with 1:100,000 epinephrine (maximum 10cc) * Graft site hemostasis with monopolar cautery * No suture closure of graft site Group 2: Basic buccal procedure + Long acting local * Infiltration of lidocaine 1% with epinephrine (maximum 10cc) * Graft site hemostasis with monopolar cautery * No suture closure of graft site * 0.5% Marcaine (maximum 5cc) at case conclusion Group 3: Basic buccal procedure + Buccal block * Infiltration of lidocaine 1% with epinephrine (maximum 10cc) * Graft site hemostasis with monopolar cautery * No suture closure of graft site * Buccal block with 0.5% Marcaine (maximum 5cc) at case conclusion

Conditions

• Urethral Stricture, Male

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-02-15
• Primary completion: 2026-03-01
• Completion: 2026-03-01
• First posted: 2022-03-29
• Last updated: 2025-10-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study