Clinical Research Directory

Inclusion Criteria * Adults scheduled for a primary unilateral bunionectomy with distal first metatarsal osteotomy and internal fixation under regional anesthesia. * Able and willing to provide informed consent and comply with study procedures. * Body weight ≥50 kg and BMI 18 to 40 kg/m². * Medically fit for surgery and study treatment based on medical history, physical examination, ECG, vital signs, and laboratory assessments. * Meets protocol-specified contraception requirements. * After surgery, reports moderate to severe pain (Verbal Rating Scale) with a Numeric Pain Rating Scale (NPRS) score ≥4 within 9 hours after removal of the popliteal sciatic block. * Able to follow commands and has complied with protocol-required perioperative analgesic guidelines. Exclusion Criteria * Clinically significant medical conditions or laboratory abnormalities that could increase risk or interfere with study assessments. * Major surgery within 6 months prior to screening or anticipated need for major surgery during the study. * Prior bunionectomy or related surgery on either applicable foot. * Peripheral neuropathy affecting the legs. * Clinically significant cardiac disease, arrhythmias, QT prolongation risk, or abnormal ECG findings. * Sleep apnea requiring positive airway pressure therapy. * American Society of Anesthesiologists (ASA) physical status classification ≥3. * Contraindication, intolerance, allergy, or unwillingness to receive study-related analgesics, NSAIDs, acetaminophen/hydrocodone, local anesthetics, or study drug components. * Participation in another interventional clinical trial within the protocol-defined exclusion period. * Significant renal impairment, hepatic impairment, positive HIV, hepatitis B, or hepatitis C tests. * History of substance abuse or addiction within the previous 3 years or positive drug/alcohol screening as specified by the protocol. * Blood or plasma donation exceeding protocol limits before screening. * Pregnant, breastfeeding, planning pregnancy during the study, or unwilling to comply with contraception requirements. * Postoperative factors precluding randomization, including unsuccessful popliteal block placement, surgical complications, non-adherence to postoperative analgesic requirements, or medical complications during surgery.