Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty (NCT05300685) | Clinical Trial Compass
Active — Not RecruitingPhase 3
Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
United States60 participantsStarted 2022-02-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.