Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 3

Conditions: Urethral Stricture, Male

Treatments: Drug: Standard Buccal Harvest; Drug: Basic buccal procedure + Long acting local; Drug: Basic buccal procedure + Buccal block

Study type: Interventional

Funder types: Other

Identifiers

NCT05300685

21-35352

Details and patient eligibility

About

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.

Full 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

Enrollment: 60 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 3 patient groups

Group 1: Standard of care

Active Comparator group

Description:

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

Treatment:

Drug: Standard Buccal Harvest

Group 2: Standard of care + Long acting local

Experimental group

Description:

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

Treatment:

Drug: Basic buccal procedure + Long acting local

Group 3: Standard of care + Buccal block

Experimental group

Description:

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

Treatment:

Drug: Basic buccal procedure + Buccal block