Status:

RECRUITING

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

Lead Sponsor:

University of California, San Francisco

Collaborating Sponsors:

MedStar Georgetown University Hospital

Conditions:

Urethral Stricture, Male

Eligibility:

MALE

18+ years

Phase:

PHASE3

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 gr...

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 co...

Eligibility Criteria

Inclusion

  • Men, age 18 or older
  • Undergoing anterior urethroplasty with buccal grafting
  • Able to consent

Exclusion

  • 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

Key Trial Info

Start Date :

February 15 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 1 2026

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT05300685

Start Date

February 15 2022

End Date

March 1 2026

Last Update

October 24 2025

Active Locations (2)

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Page 1 of 1 (2 locations)

1

University of California San Francisco

San Francisco, California, United States, 94143

2

MedStar Urology

Washington D.C., District of Columbia, United States, 20037