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NCT Number: NCT05300685

Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

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.

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Key information

Conditions

Urethral Stricture, Male Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urethral Diseases Urethral Obstruction Urethral Stricture Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

University of California San Francisco, San Francisco, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Standard Buccal Harvest

Drug

Our institutions current anesthetic regimen. Comparison group

Basic buccal procedure + Long acting local

Drug

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

Basic buccal procedure + Buccal block

Drug

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

Primary outcomes

  1. Change(s) in Post-operative pain

    Time frame: Postoperative Day 1, 5, 10

    The Wong-Baker FACES pain scale is a validated scale where a score of 0 is no pain and 10 is the worst pain imaginable. Pain greater than or equal to 5 would result in significant limitations on daily life.

    Oral, incisional (surgical site), and overall pain will each be assigned a score of 0-10 at each time point (9 total scores).

Secondary outcomes

  1. Change(s) in Post-operative Narcotic use

    Time frame: Postoperative Day 1, 5, 10

    Patient measure of number of oxycodone tablets taken (0-5). Patient request for additional narcotic medicaiton (Yes/No) Patient measure of adherence to non-narcotic pain regiman (Yes/No)

Other outcomes

  1. Peri-operative Complications

    Time frame: Postoperative Day 0-30

    Clavien-Dingo is a validated tool to measure the severity of post-operative outcomes. Class I are mild and require no treatment. Class V is death.

Study contacts

Contact information is provided by the study sponsor or research team.

Lindsay A Hampson, MD

CONTACT

[email protected]

415-353-2200

Sara Z Amare, BS

CONTACT

[email protected]

(415) 514-7597

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • MedStar Georgetown University Hospital

Registry information

Official study title

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

Acronym: Buccal

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 29, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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