Post-Operative Pain and Opioid Reduction Trial After Bunionectomy

Inclusion Criteria: * Be willing and able to sign the informed consent form (ICF) prior to study participation * In the medical judgment of the Investigator, be a reasonably healthy adult 18 - 75 years of age, inclusive, and ASA Class I or II at the time of randomization * Plan to undergo an elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries * Have a BMI ≤ 39 kg/m2 Exclusion Criteria: * Previous unilateral simple bunionectomy * Has a planned concurrent surgical procedure that may impact pain scores, rescue medication use, or ability to fulfill the requirements of the protocol * Concurrent painful condition * Active skin disease or other clinically significant abnormality at the anticipated surgical site that could interfere with the planned surgery * Known hypersensitivity or known allergy, as determined by the Investigator, to the ingredients (i.e., excipients) of the study drug or any peri- or postoperative medications used in this study * History or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments * History of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency * History or evidence of impaired liver function (e.g., ALT \> 3 × upper limit of normal \[ULN\] or total bilirubin \> 2 × ULN), active hepatic disease, or cirrhosis * History or evidence of impaired renal function (e.g., creatinine \> 1.5 × ULN) * History of malignancy in the past year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized in situ carcinoma of the cervix * Has or has had active COVID-19 infection within 3 months prior to surgery

Reproduced word-for-word from the public registry record — the study team can answer questions about it.