Clinical Research Directory

Key Inclusion Criteria: Before Surgery: * Participant scheduled to undergo a primary unilateral bunionectomy with distal first metatarsal osteotomy (i.e., Austin procedure) and internal fixation under regional anesthesia (Mayo block) After Surgery: * Participant is lucid and able to follow commands * All analgesic guidelines were followed during and after the bunionectomy Key Exclusion Criteria: Before Surgery: * Prior history of bunionectomy or other foot surgery on the index foot * History of cardiac dysrhythmias requiring anti-arrhythmia treatment(s) within the last 2 years * A known or clinically suspected active infection with human immunodeficiency virus or hepatitis B or C viruses After Surgery: * Participant had a Type 3 deformity requiring a base wedge osteotomy or concomitant surgery such as hammertoe repair, or had medical complications during the bunionectomy Other protocol defined inclusion/exclusion criteria may apply.