Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
estimated completion
Principal Investigator
by Lindsay Hampson, MD
Headshot of Lindsay Hampson
Lindsay Hampson

Description

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.

Official Title

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic

Details

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 control. Each study arm holds equal weight. Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive the following graft harvest techniques, which are all considered standard of care. Group 1: Current Buccal Harvest - Infiltration of lidocaine 1% with 1:100,000 epinephrine (maximum 10cc) - Graft site hemostasis with monopolar cautery - No suture closure of graft site Group 2: Basic buccal procedure + Long acting local - Infiltration of lidocaine 1% with epinephrine (maximum 10cc) - Graft site hemostasis with monopolar cautery - No suture closure of graft site - 0.5% Marcaine (maximum 5cc) at case conclusion Group 3: Basic buccal procedure + Buccal block - Infiltration of lidocaine 1% with epinephrine (maximum 10cc) - Graft site hemostasis with monopolar cautery - No suture closure of graft site - Buccal block with 0.5% Marcaine (maximum 5cc) at case conclusion

Keywords

Urethral Stricture, Male buccal urethroplasty urethral stricture urethroplasty buccal block lidocaine Constriction, Pathologic Basic buccal procedure + Long acting local Basic buccal procedure + Buccal block

Eligibility

You can join if…

Open to males ages 18 years and up

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

You CAN'T join if...

  • 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

Location

  • University of California San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Lindsay Hampson, MD
    Assistant Professor, Urology, School of Medicine. Authored (or co-authored) 53 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05300685
Phase
Phase 3 research study
Study Type
Interventional
Last Updated