CPL-01 in the Management of Postoperative Pain After Bunionectomy

Inclusion Criteria: Ability to sign ICF Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with osteotomy and internal fixation under regional anesthesia, without collateral procedures or additional surgeries BMI ≤ 39 kg/m2 If biologically female, not pregnant or planning to become pregnant over the study If biologically male, either sterile or using acceptable form of birth control Be willing and able to complete study procedures Exclusion Criteria: Has previously undergone unilateral simple bunionectomy. Has a planned concurrent surgical procedure Has a concurrent painful condition that may require analgesic treatment during the study period or may confound postsurgical pain assessments Has a history or clinical manifestation of significant medical, neuropsychiatric, or other condition that could preclude or impair study participation or interfere with study assessments. Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase deficiency. Has history or evidence of impaired liver function (e.g., alanine aminotransferase [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active hepatic disease, or cirrhosis. Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN). Has a history of malignancy in the past year Has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months