← Back to Search

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
Must not have
Hematologic condition that excludes patient from surgery
Anesthetic complication
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 1, 5, 10
Awards & highlights

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My blood condition prevents me from having surgery.
Select...
I have had complications with anesthesia before.
Select...
I had complications after surgery that required a hospital stay.
Select...
I cannot use Tylenol due to liver issues or an allergy.
Select...
My heart condition severely limits my physical activity.
Select...
I have been diagnosed with chronic pain.
Select...
I have had surgery to repair the urethra in my mouth area before.
Select...
I cannot use NSAIDs due to kidney problems or allergies.
Select...
I have had no complications from mouth surgery.

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

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

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Group 3: Standard of care + Buccal blockExperimental Treatment1 Intervention
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 II: Group 2: Standard of care + Long acting localExperimental Treatment1 Intervention
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 III: Group 1: Standard of careActive Control1 Intervention
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

Find a Location

Who is running the clinical trial?

MedStar Georgetown University HospitalOTHER
5 Previous Clinical Trials
22,809 Total Patients Enrolled
University of California, San FranciscoLead Sponsor
2,551 Previous Clinical Trials
15,257,826 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
~21 spots leftby Mar 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top