Clinical trial NCT05300685: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Urethral Stricture, Male
Keywords: buccal urethroplasty
urethral stricture
urethroplasty
buccal block
lidocaine
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: MedStar Georgetown University Hospital
First posted: 2022-03-29
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change(s) in Post-operative pain
timeFrame: Postoperative Day 1, 5, 10
Secondary outcomes:
measure: Change(s) in Post-operative Narcotic use
timeFrame: Postoperative Day 1, 5, 10
Other outcomes:
measure: Peri-operative Complications
timeFrame: Postoperative Day 0-30
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Washington
country: United States
facility: MedStar Urology
state: District of Columbia
Study officials:
affiliation: University of California, San Francisco
name: Lindsay Hampson, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.