Adductor Canal Block and IPACK Block vs. Isolated Adductor Canal Block for Post-Operative Analgesia Following ACL Reconstruction With Bone Patellar Tendon Bone Autograft: A Single Center Randomized Placebo-Controlled Trial

22-00148

A randomized, single-blind, single-center study measuring the effects of adductor canal block combined with IPACK infiltration compared to adductor canal block alone on post-operative pain and opioid consumption in patients undergoing ACL reconstruction with Bone Patellar Tendon Bone Autograft

2022-07-11

2023-03-31

2023-12-18

Completed

Early phase I

102

Inclusion Criteria: * Patients between 18 and 75 years of age * Patients undergoing primary ACL reconstruction with BPTB Autograft * ASA I or II Exclusion Criteria: * Patients younger than 18 and older than 75. * Patients with multi-ligament injury * Patients undergoing concomitant cartilage procedure or osteotomy. * Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer. * Patients who are allergic to oxycodone; * Patients with diagnosed or self-reported cognitive dysfunction; * Patients with a history of neurologic disorder that can interfere with pain sensation; * Patients with a history of drug or recorded alcohol abuse; * Patients who are unable to understand or follow instructions; * Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; * Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; * Patients with a BMI over 45; * Any patient that the investigators feel cannot comply with all study related procedures; * Any pregnant patient; assessed via urine pregnancy test in the preoperative area as part of standard preoperative surgical protocol;

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 102, 'type': 'ACTUAL'}}

2024-04-26