Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty (Buccal)

  • STATUS
    Recruiting
  • End date
    Mar 1, 2023
  • participants needed
    60
  • sponsor
    University of California, San Francisco
Updated on 19 April 2022

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.

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 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

Details
Condition Urethral Stricture, Male
Treatment Standard Buccal Harvest, Basic buccal procedure + Long acting local, Basic buccal procedure + Buccal block
Clinical Study IdentifierNCT05300685
SponsorUniversity of California, San Francisco
Last Modified on19 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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