Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard Buccal Harvest, Basic buccal procedure + Long acting local, Basic buccal procedure + Buccal block.
- Who it may be relevant to
- Registry conditions: Urethral Stricture, Male. Basic parameters: from 18 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty: Randomized Control Trial of Harvest Site Anesthetic
Overview
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
Interventions
- 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
Primary outcome measures
- Change(s) in Post-operative pain [Time frame: Postoperative Day 1, 5, 10]
Secondary outcome measures (1)
- Change(s) in Post-operative Narcotic use [Time frame: Postoperative Day 1, 5, 10]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- University of California San Francisco — San Francisco
- MedStar Urology — Washington D.C.
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. PMID 31057252
- 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. PMID 22119261
- 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. PMID 22889835
Identifiers
NCT: NCT05300685 · 21-35352