RecruitingPhase 3NCT05300685

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

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


Sponsor

University of California, San Francisco

Enrollment

60 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria13

  • 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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Interventions

DRUGStandard Buccal Harvest

Our institutions current anesthetic regimen. Comparison group

DRUGBasic buccal procedure + Long acting local

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

DRUGBasic buccal procedure + Buccal block

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


Locations(2)

University of California San Francisco

San Francisco, California, United States

MedStar Urology

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

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NCT05300685