Peri-operative Oral Pain Control Following Buccal Graft Urethroplasty
Recruiting
Phase 3Interventional Study
Urethral Stricture, Male
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Male
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
60 (estimated)
Sponsor
University of California, San Francisco · Other
Who this trial is looking for
This trial is looking for men aged 18 or older who are having surgery to fix a narrowing in the urethra using tissue from the inside of the cheek. Participants will receive different methods of pain relief during and after the surgery to see which one works best.
Are You a Good Fit for This Trial?
Rules you outNYHA Class III/IVHematologic condition
You may be able to join if
I am a man aged 18 or older
I am having surgery for a urethral stricture
I can give my consent to participate
You may not be able to join if
I have been taking painkillers regularly
I have chronic pain
I have had this urethra surgery before
I am part of a vulnerable population
I have kidney problems or allergies to NSAIDs
I have liver problems or allergies to Tylenol
I have an allergy to local anesthetics
I have an allergy to Peridex or Magic Mouthwash
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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…
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.
Trial Locations
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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 aller…
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
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