Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial

SHAM2023-2163

Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic that was initially utilized as an infiltrative agent but has more recently become U.S. Food and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL) reconstruction.

2023-08-21

2024-10-30

2024-10-30

Early phase I

154

Inclusion Criteria: * Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified in clinic by one of 4 different surgeons * Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral extra-articular tenodesis * Age 18 and older * English speaking * Ability to complete surveys by phone or in person * Ability to provide informed consent Exclusion Criteria: * Revision cases * Multi-ligamentous knee injuries * Cartilage or meniscal procedures that prevent adherence to immediate weight bearing and range of motion rehab protocol * ACL reconstruction utilizing non-bone-patellar tendon-bone autografts * Allergies to study medications * Non-English speakers * Known alcohol or narcotic abuse history * Existing contract with a pain specialist due to underlying preoperative pain syndrome * Preoperative opioid use within the 3 months prior to surgery

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}}, 'enrollmentInfo': {'count': 154, 'type': 'ESTIMATED'}}

2023-08-23