Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients

HM20025041

Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. The liposomal formulation of bupivacaine, however, has a length of therapeutic effect of up to 72 hours. Typical post-operative incisional pain is known to last for several days in most cases and is thought to peak between 1-2 days after surgery. Therefore, the benefit of most short-acting local analgesics does not overlap with the period of most need.

2023-01-31

2025-01-01

2025-01-01

Recruiting

Early phase I

50

Inclusion Criteria: * patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity who are between 13 and 2018 years of age. * Only patients treated at the Children's Hospital of Richmond at VCU will be included. Exclusion Criteria: * patients less than 13 or greater than 2018 years of age * patients with an allergy to bupivacaine * any patients undergoing any additional procedures at the time of the laparoscopic sleeve gastrectomy. * English or Spanish proficiency will be necessary.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will randomly be treated with either liposomal bupivacaine (study drug) or standard bupivacaine after undergoing bariatric surgery.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'maskingDescription': 'Patients will not be told the group to which they were assigned and will have been under anesthesia for administration. The surgeon, other clinical team members, and the study staff will not be blinded to the study group assignment.', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-10-16