Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

Conditions

• Urethral Stricture, Male

Eligibility Criteria

Sex

MALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Standard Buccal Harvest — DRUG
  Our institutions current anesthetic regimen. Comparison group
• Basic buccal procedure + Long acting local — DRUG
  Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
• Basic buccal procedure + Buccal block — DRUG
  Addition of long-acting local anesthetic as a buccal block after oral graft harvest

Study Details

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.

Key Dates

Start date

Feb 15, 2022

Status verified

Jun 2026

Primary completion

Jul 1, 2026

Completion

Jul 1, 2026

Study Design

Enrollment

60 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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

Primary Outcome Measure

Change(s) in Post-operative pain [ Time Frame: Postoperative Day 1, 5, 10 ]

Central Contacts

• Lindsay A Hampson, MD
  415-353-2200
  [email protected]
• Sara Z Amare, BS
  (415) 514-7597
  [email protected]

Locations (2)

Find similar trials in San Francisco, CA