Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

NCT05300685 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 21-35352
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Urethral Stricture, Male

Keywords

buccal urethroplasty; urethral stricture; urethroplasty; buccal block; lidocaine

Outcome Measures

Primary Outcomes (1)

• Change(s) in Post-operative pain

  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).

  Postoperative Day 1, 5, 10

Secondary Outcomes (1)

• Change(s) in Post-operative Narcotic use

  Postoperative Day 1, 5, 10

Other Outcomes (1)

• Peri-operative Complications

  Postoperative Day 0-30

Study Arms (3)

Group 1: Standard of care

ACTIVE COMPARATOR

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

Drug: Standard Buccal Harvest

Group 2: Standard of care + Long acting local

EXPERIMENTAL

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

Drug: Basic buccal procedure + Long acting local

Group 3: Standard of care + Buccal block

EXPERIMENTAL

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

Drug: Basic buccal procedure + Buccal block

Interventions

Standard Buccal Harvest DRUG

Our institutions current anesthetic regimen. Comparison group

Group 1: Standard of care

Basic buccal procedure + Long acting local DRUG

Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.

Group 2: Standard of care + Long acting local

Basic buccal procedure + Buccal block DRUG

Addition of long-acting local anesthetic as a buccal block after oral graft harvest

Group 3: Standard of care + Buccal block

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men, age 18 or older
• Undergoing anterior urethroplasty with buccal grafting
• Able to consent

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• MedStar Georgetown University Hospital: collaborator

Study Sites (2)

University of California San Francisco

San Francisco, California, 94143, United States

RECRUITING

MedStar Urology

Washington D.C., District of Columbia, 20037, United States

RECRUITING

Related Publications (3)

• Jonnavithula N, Bachu D, Sriramoju V, Devraj R, Gunta R, Pisapati MVLN. Effect of infraorbital nerve block on postoperative pain and 30-day morbidity at the donor site in buccal mucosal graft urethroplasty. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):114-118. doi: 10.4103/joacp.JOACP_211_17.

  PMID: 31057252 BACKGROUND

• Rourke K, McKinny S, St Martin B. Effect of wound closure on buccal mucosal graft harvest site morbidity: results of a randomized prospective trial. Urology. 2012 Feb;79(2):443-7. doi: 10.1016/j.urology.2011.08.073. Epub 2011 Nov 25.

  PMID: 22119261 BACKGROUND

• Lumen N, Oosterlinck W, Hoebeke P. Urethral reconstruction using buccal mucosa or penile skin grafts: systematic review and meta-analysis. Urol Int. 2012;89(4):387-94. doi: 10.1159/000341138. Epub 2012 Aug 9.

  PMID: 22889835 BACKGROUND

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Lindsay Hampson, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lindsay A Hampson, MD

CONTACT

415-353-2200; lindsay.hampson@ucsf.edu

Sara Z Amare, BS

CONTACT

(415) 514-7597; sara.amare@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive 3 different local anesthetic regimens following buccal graft harvest. The care provider administering will not be masked to the type of block, but they will be blinded to the post op outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: March 29, 2022
• Study Start: February 15, 2022
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)