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

• ClinicalTrials.gov Identifier: NCT05300685
• Recruitment Status: Recruiting
• First Posted: March 29, 2022
• Last Update Posted: March 29, 2022
• Sponsor: University of California, San Francisco
• Information provided by (Responsible Party): University of California, San Francisco

Tracking Information

• First Submitted Date: March 15, 2022
• First Posted Date: March 29, 2022
• Last Update Posted Date: March 29, 2022
• Actual Study Start Date: February 15, 2022
• Estimated Primary Completion Date: March 1, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 24, 2022)

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).

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: March 24, 2022)

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)

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 24, 2022)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

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

Brief 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.

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
• Study Phase: Phase 3

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model 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.

Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

Approximately 60 subjects will be randomized in a 1:1:1 ratio to receive 3 different local anesthetic regimens following buccal graft harvest. The care provider administering will not be masked to the type of block, but they will be blinded to the post op outcomes.

Primary Purpose: Treatment

• Condition: Urethral Stricture, Male

Intervention

• Drug: Standard Buccal Harvest
  Our institutions current anesthetic regimen. Comparison group
• Drug: Basic buccal procedure + Long acting local
  Addition of long-acting local anesthetic to the wound bed following the oral graft harvest.
• Drug: Basic buccal procedure + Buccal block
  Addition of long-acting local anesthetic as a buccal block after oral graft harvest

Study Arms

• Active Comparator: Group 1: Standard of care
  1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
  2. Routine, standard graft site hemostasis with monopolar cautery
  3. No suture closure of graft site
  4. No further infiltration of local anesthetic in mouth
  Intervention: Drug: Standard Buccal Harvest
• Experimental: Group 2: Standard of care + Long acting local
  1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
  2. Routine, standard graft site hemostasis with monopolar cautery
  3. No suture closure of graft site
  4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration in the buccal graft site
  Intervention: Drug: Basic buccal procedure + Long acting local
• Experimental: Group 3: Standard of care + Buccal block
  1. Prior to graft harvest - infiltration of 1% lidocaine with 1:100,000 epinephrine up to a maximum of 10 mL
  2. Routine, standard graft site hemostasis with monopolar cautery
  3. No suture closure of graft site
  4. Up to a maximum of 10mL of 0.5% bupivacaine infiltration as a buccal block
  Intervention: Drug: Basic buccal procedure + Buccal block

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.

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 24, 2022): 60
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 1, 2023
• Estimated Primary Completion Date: March 1, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lindsay A Hampson, MD; 415-353-2200; lindsay.hampson@ucsf.edu

Contact: Rory Grant; (415) 353-7615; rory.grant2@ucsf.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05300685
• Other Study ID Numbers: 21-35352
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: University of California, San Francisco
• Original Responsible Party: Same as current
• Current Study Sponsor: University of California, San Francisco
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of California, San Francisco
• Verification Date: March 2022