CPL-01 in the Management of Postoperative Pain After Bunionectomy

Launched by CALI PHARMACEUTICALS LLC · Apr 25, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called CPL-01 to see how well it helps manage pain after bunion surgery, specifically a procedure called bunionectomy. Researchers want to find out if patients who receive CPL-01 will experience less pain and need fewer opioid medications compared to those receiving standard treatments. The trial is currently looking for participants aged 18 to 74 who have a bunion and are planning to have this surgery.

To be eligible for the trial, participants must be able to sign a consent form, have a bunion that requires surgery, and meet certain health criteria, such as having a body mass index (BMI) of 39 or lower. Women cannot be pregnant or planning to become pregnant, and men must either be sterile or use birth control. Those who have had previous bunion surgery, are scheduled for other surgeries, or have certain medical conditions may not qualify. If you join the study, you'll receive the study medication during your surgery and be monitored for pain levels and how much opioid medication you use afterward. Your participation will help researchers learn more about pain management options for bunion surgery.

Gender

ALL

Eligibility 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