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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

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

No Placebo-Only Group

Pivotal 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.

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

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My blood condition prevents me from having surgery.

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I have had complications with anesthesia before.

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I had complications after surgery that required a hospital stay.

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I cannot use Tylenol due to liver issues or an allergy.

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My heart condition severely limits my physical activity.

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I have been diagnosed with chronic pain.

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I have had surgery to repair the urethra in my mouth area before.

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I cannot use NSAIDs due to kidney problems or allergies.

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I have had no complications from mouth surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ postoperative day 1, 5, 10

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

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

0 / 11Eligibility criteria met