Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• Men, age 18 or older
• Undergoing anterior urethroplasty with buccal grafting
• Able to consent
Locations
United States
California
University of California San Francisco
RECRUITING
San Francisco
Washington, D.c.
MedStar Urology
RECRUITING
Washington D.c.
Contact Information
Primary
Lindsay A Hampson, MD
lindsay.hampson@ucsf.edu
415-353-2200
Backup
Rory Grant
rory.grant2@ucsf.edu
(415) 353-7615
Time Frame
Start Date:2022-02-15
Estimated Completion Date:2026-03-01
Participants
Target number of participants:60
Treatments
Active_comparator: Group 1: Standard of care
1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL~2. Routine, standard graft site hemostasis with monopolar cautery~3. No suture closure of graft site~4. No further infiltration of local anesthetic in mouth
Experimental: Group 2: Standard of care + Long acting local
1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL~2. Routine, standard graft site hemostasis with monopolar cautery~3. No suture closure of graft site~4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site
Experimental: Group 3: Standard of care + Buccal block
1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL~2. Routine, standard graft site hemostasis with monopolar cautery~3. No suture closure of graft site~4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block