Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty

Urethral Stricture, Male Clinical Trial

— Buccal  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05300685
• Other study ID #: 21-35352
• Status: Recruiting
• Phase: Phase 3
• Start date: February 15, 2022
• Est. completion date: March 1, 2026

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: Lindsay A Hampson, MD
• Phone: 415-353-2200
• Email: lindsay.hampson[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture
• Urethral Stricture, Male

Intervention

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

Locations

Country	Name	City	State
United States	University of California San Francisco	San Francisco	California
United States	MedStar Urology	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	MedStar Georgetown University Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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