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Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

NCT05300685 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-10-24

No results posted yet for this study

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 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.

Conditions

  • Urethral Stricture, Male

Interventions

DRUG

Standard Buccal Harvest

Our institutions current anesthetic regimen. Comparison group

DRUG

Basic buccal procedure + Long acting local

Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.

DRUG

Basic buccal procedure + Buccal block

Addition of long-acting local anesthetic as a buccal block after oral graft harvest

Sponsors & Collaborators

Principal Investigators

  • Lindsay Hampson, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-15
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05300685 on ClinicalTrials.gov