Clinical Research Directory

Inclusion Criteria: * Is medically fit to undergo an elective unilateral, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia; no neuraxial technique (eg, no spinal, epidural, or general anesthesia). * Has an American Society of Anesthesiologists (ASA) Physical Status of I, II, or III. * Female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study; sterile, or using acceptable contraceptives. Exclusion Criteria: * Had contralateral foot bunionectomy in the past 3 months. * Has a planned concurrent surgical procedure. * Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * Has received or is taking a contraindicated or prohibited medications. * Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives. * Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. * Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months. * Has a history of coronary artery bypass graft surgery within 12 months. * Has a history of known or suspected coagulopathy. * As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV). * Has uncontrolled anxiety, psychiatric, or neurological disorder. * Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix. * Has undergone 3 or more surgeries within 12 months. * Has a known history of glucose-6-phosphate dehydrogenase deficiency. * Has any of the following laboratory abnormalities during Screening (1 retest permitted): * Severe liver function impairment. * Severe kidney function impairment. * Platelet count \<100,000/μL, hemoglobin \<12 g/dL, or hematocrit \<35%. * Has a body mass index (BMI) \>39 kg/m2.