Liposomal Bupivacaine To Control Post-Operative Pain Following BMG

• Status: Completed
• Trial end date: 2017-10-31
• Target enrollment: 0
• Participant gender: Male

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Urology of Virginia
• Treatments: Bupivacaine

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

• 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