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Local Anesthetic

Anesthetic Protocols for Oral Pain After Urethral Surgery (Buccal Trial)

Phase 3
Recruiting
Led By Lindsay Hampson, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men, age 18 or older
Undergoing anterior urethroplasty with buccal grafting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 1, 5, 10
Awards & highlights

Buccal Trial Summary

This trial will compare 3 different anesthetic protocols for oral pain control in patients undergoing buccal urethroplasty.

Who is the study for?
This trial is for men aged 18 or older who are undergoing anterior urethroplasty with buccal grafting and can consent. It's not for those with certain blood conditions, anesthetic complications, chronic pain issues, severe heart problems (NYHA Class III/IV), liver or kidney dysfunctions that prevent the use of common pain relievers, allergies to specific mouthwashes or local anesthetics, prisoners, or anyone previously treated with buccal urethroplasty.Check my eligibility
What is being tested?
The study tests three anesthesia methods for managing oral pain after a surgery involving a cheek tissue graft in the urethra. Patients will be randomly assigned to receive either a basic procedure plus a buccal block, standard harvest technique without additional blocks, or basic procedure plus long-acting local anesthesia. The goal is to see which method best reduces post-op pain.See study design
What are the potential side effects?
Potential side effects may include adverse reactions at the site where the local anesthetic is administered such as swelling or infection; allergic reactions to medications used; and typical surgical risks like bleeding and prolonged soreness at both the graft and surgery sites.

Buccal Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a man aged 18 or older.
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I am having surgery to repair my urethra using tissue from my mouth.

Buccal Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 1, 5, 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and postoperative day 1, 5, 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change(s) in Post-operative pain
Secondary outcome measures
Change(s) in Post-operative Narcotic use
Other outcome measures
Peri-operative Complications

Buccal Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: Standard of care + Buccal blockExperimental Treatment1 Intervention
Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL Routine, standard graft site hemostasis with monopolar cautery No suture closure of graft site Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block
Group II: Group 2: Standard of care + Long acting localExperimental Treatment1 Intervention
Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL Routine, standard graft site hemostasis with monopolar cautery No suture closure of graft site Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site
Group III: Group 1: Standard of careActive Control1 Intervention
Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL Routine, standard graft site hemostasis with monopolar cautery No suture closure of graft site No further infiltration of local anesthetic in mouth

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,738 Total Patients Enrolled
2 Trials studying Urethral Stricture
245 Patients Enrolled for Urethral Stricture
Lindsay Hampson, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Basic buccal procedure + Buccal block (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT05300685 — Phase 3
Urethral Stricture Research Study Groups: Group 1: Standard of care, Group 2: Standard of care + Long acting local, Group 3: Standard of care + Buccal block
Urethral Stricture Clinical Trial 2023: Basic buccal procedure + Buccal block Highlights & Side Effects. Trial Name: NCT05300685 — Phase 3
Basic buccal procedure + Buccal block (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05300685 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants being recruited for this experiment at this time?

"The latest information from clinicaltrials.gov suggests that this trial is still recruiting patients. The original posting was on February 15th, 2022 with the most recent edit taking place on March 24th of the same year."

Answered by AI

How many people are chosen to participate in this clinical trial?

"Yes, this information is accurate. The trial was first posted on February 15th, 2022 and is currently looking for 60 more patients from a single location."

Answered by AI

What is the long-term prognosis for patients who undergo Basic buccal procedure + Buccal block?

"This medical procedure, which is a Phase 3 trial, has been given a safety rating of 3. This is due to the both efficacy data and supporting safety data that has been gathered in previous studies."

Answered by AI
Recent research and studies
~19 spots leftby Mar 2025