Liposomal Bupivacaine To Control Post-Operative Pain Following BMG

Completed · Phase 3

Conditions studied: Urethral Stricture

In brief

This is a single blinded-randomized controlled trial that recruit male patients for substitution urethroplasty using buccal mucosal graft. The study investigators aim to assess the efficacy and safety of liposomal bupivacaine injection to the buccal graft harvest site on post-operative main score, morphine equivalence requirement and oral morbidities.

Key facts

Study ID

NCT03720223

Run by

Urology of Virginia

People needed

50

Starts

2015-01-20

Expected to finish

2017-10-31

Last updated by the study team

2021-10-01

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• male adults with urethral stricture assessed to be requiring a urethroplasty with BMG harvesting

You may not qualify if…

• female adult patient with urethral strictures
• prior diagnosis of chronic pain or systemic disease that would interfere with outcome assessment or metabolism of the local anesthetics or narcotics.
• allergy to liposomal content or bupivacaine or any cross reaction to local anesthetics
• neurological disease with impaired communication or neurological deficit to pain
• with poor oral health with lesions
• urethroplasties with no requirement for BMG graft
• on daily narcotic requirement pre-operatively
• on daily analgesia medication required for other condition
• consented for other clinical trials which may interfere the outcome assessment
• unwilling for post-operative interview or survey involvement

Where it is running

• Urology of Virginia — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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