CPL-01 in the Management of Postoperative Pain After Bunionectomy

• Status: Not yet recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cali Pharmaceuticals LLC
• Treatments: Anesthetics; Anesthetics, Local; Ropivacaine

Criteria

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