Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

NCT ID: NCT05300685

Last Updated: 2025-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-15
• Study Completion Date: 2026-03-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Standard Buccal Harvest

Intervention Type: DRUG

Our institutions current anesthetic regimen. Comparison group

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

Group Type: EXPERIMENTAL

Basic buccal procedure + Long acting local

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Basic buccal procedure + Buccal block

Intervention Type: DRUG

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

Interventions

Standard Buccal Harvest

Our institutions current anesthetic regimen. Comparison group

Intervention Type: DRUG

Basic buccal procedure + Long acting local

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

Intervention Type: DRUG

Basic buccal procedure + Buccal block

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

MedStar Georgetown University Hospital

OTHER

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lindsay Hampson, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California San Francisco

San Francisco, California, United States

Site Status: RECRUITING

MedStar Urology

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

Site Status: RECRUITING

Countries

United States

Central Contacts

Lindsay A Hampson, MD

Role: CONTACT

lindsay.hampson@ucsf.edu

415-353-2200

Sara Z Amare, BS

Role: CONTACT

sara.amare@ucsf.edu

(415) 514-7597

Facility Contacts

Lindsay A Hampson, MD

Role: primary

lindsay.hampson@ucsf.edu

415-353-2200

Nathan Shaw, MD

Role: primary

nathan.m.shaw@medstar.net

202-444-4922

Krishnan Venkatesan, MD

Role: backup

krishnan.venkatesan@medstar.net

2024444922

References

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.

Reference Type: BACKGROUND

PMID: 31057252 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22119261 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22889835 (View on PubMed)

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

21-35352

Identifier Type: -

Identifier Source: org_study_id