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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urethral Stricture, Male
• Intervention / Treatment: Drug: Standard Buccal Harvest; Drug: Basic buccal procedure + Long acting local; Drug: Basic buccal procedure + Buccal block

Detailed 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

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Lindsay A Hampson, MD; Phone Number: 415-353-2200; Email: lindsay.hampson@ucsf.edu
• Study Contact Backup: Name: Rory Grant; Phone Number: (415) 353-7615; Email: rory.grant2@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California San Francisco
      • Contact: Lindsay A Hampson, MD; Phone Number: 415-353-2200; Email: lindsay.hampson@ucsf.edu
      • Sub-Investigator: Nathan M Shaw, MD
      • Principal Investigator: Lindsay A Hampson, MD
      • Sub-Investigator: Benjamin N Breyer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 1: Standard of care; Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL; Routine, standard graft site hemostasis with monopolar cautery; No suture closure of graft site; No further infiltration of local anesthetic in mouth	Drug: Standard Buccal Harvest; Our institutions current anesthetic regimen. Comparison group
Experimental: Group 2: Standard of care + Long acting local; Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL; Routine, standard graft site hemostasis with monopolar cautery; No suture closure of graft site; Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site	Drug: Basic buccal procedure + Long acting local; Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
Experimental: Group 3: Standard of care + Buccal block; Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL; Routine, standard graft site hemostasis with monopolar cautery; No suture closure of graft site; Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block	Drug: Basic buccal procedure + Buccal block; Addition of long-acting local anesthetic as a buccal block after oral graft harvest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change(s) in Post-operative pain	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).	Postoperative Day 1, 5, 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change(s) in Post-operative Narcotic use	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)	Postoperative Day 1, 5, 10

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peri-operative Complications	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.	Postoperative Day 0-30

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Lindsay Hampson, MD, University of California, San Francisco

Publications and helpful links

General Publications

• Jonnavithula N, Bachu D, Sriramoju V, Devraj R, Gunta R, Pisapati MVLN. Effect of infraorbital nerve block on postoperative pain and 30-day morbidity at the donor site in buccal mucosal graft urethroplasty. J Anaesthesiol Clin Pharmacol. 2019 Jan-Mar;35(1):114-118. doi: 10.4103/joacp.JOACP_211_17.
• Rourke K, McKinny S, St Martin B. Effect of wound closure on buccal mucosal graft harvest site morbidity: results of a randomized prospective trial. Urology. 2012 Feb;79(2):443-7. doi: 10.1016/j.urology.2011.08.073. Epub 2011 Nov 25.
• Lumen N, Oosterlinck W, Hoebeke P. Urethral reconstruction using buccal mucosa or penile skin grafts: systematic review and meta-analysis. Urol Int. 2012;89(4):387-94. doi: 10.1159/000341138. Epub 2012 Aug 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Anticipated): March 1, 2024
• Study Completion (Anticipated): March 1, 2024

Study Registration Dates

• First Submitted: March 15, 2022
• First Submitted That Met QC Criteria: March 24, 2022
• First Posted (Actual): March 29, 2022

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 1, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: lidocaine; urethral stricture; urethroplasty; buccal urethroplasty; buccal block
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: 21-35352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes