Clinical Research Directory

Inclusion Criteria: The main inclusion criteria include but are not limited to the following: * Has a bunion and is scheduled to undergo a primary, unilateral bunionectomy that includes distal first metatarsal osteotomy (ie, Austin procedure) with internal fixation * Has a body mass index (BMI) of 18 to \<40 kg/m\^2 * Reports moderate or severe pain on the Pain Severity (Verbal Rating Scale) VRS and reports a pain score of ≥4 on the Numeric Pain Rating Scale (NPRS) (Brief Pain Inventory-Short Form \[BPI-SF\] "Pain Now" Item), within 2 to 9 hours of popliteal block discontinuation * Has bunionectomy under regional anesthesia using a Mayo block, popliteal sciatic block and monitored anesthesia care (MAC) Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has any of the following conditions in the index joint: * Has a Type 3 deformity requiring a base wedge osteotomy * Requires a concomitant surgery such as hammertoe repair or arthrodesis (fusion of the index toe) * Has had a prior bunionectomy or other foot surgery on the index foot * Has a painful, comorbid condition in the index joint, such as arthritis, that could confound the participant's assessment of postsurgical pain * Has an acute or chronic painful physical condition, surgical history, or sensory abnormality that may confound the ability of the participant to assess postoperative pain in the index joint * Has a cardiac dysrhythmia (eg, atrial fibrillation), or known structural heart disease (eg, cardiomyopathy) * Has a personal history of Brugada syndrome or 2 or more unexplained syncopal events * Has a known first degree relative with 2 or more unexplained syncopal events, unexplained cardiac arrest, sudden cardiac death or Brugada syndrome * Has a diagnosis of sleep apnea or uses a home continuous positive airway pressure machine * Has a history of peptic ulcer disease or gastrointestinal bleeding * Has a history of allergy or adverse reaction to opioid(s), acetaminophen (APAP), midazolam, volatile anesthetics, propofol, rocuronium, vecuronium, sugammadex, lidocaine, ondansetron, and/or promethazine * Has a history of hepatitis or liver disease that has been active within the 12 months * Has a history of malignancy, ≤ 3 years prior, except for successfully treated nonmelanoma skin cancer, prostate cancer, or localized carcinoma in situ of the cervix