CPL-01 in the Management of Postoperative Pain After Bunionectomy
- Conditions
- Bunion
- Registration Number
- NCT05831449
- Lead Sponsor
- Cali Pharmaceuticals LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 574
Inclusion Criteria:<br><br> - Ability to sign ICF<br><br> - Bunion for elective primary unilateral, distal, first metatarsal bunionectomy with<br> osteotomy and internal fixation under regional anesthesia, without collateral<br> procedures or additional surgeries<br><br> - BMI = 39 kg/m2<br><br> - If biologically female, not pregnant or planning to become pregnant over the study<br><br> - If biologically male, either sterile or using acceptable form of birth control<br><br> - Be willing and able to complete study procedures<br><br>Exclusion Criteria:<br><br> - Has previously undergone unilateral simple bunionectomy.<br><br> - Has a planned concurrent surgical procedure<br><br> - Has a concurrent painful condition that may require analgesic treatment during the<br> study period or may confound postsurgical pain assessments<br><br> - Has a history or clinical manifestation of significant medical, neuropsychiatric, or<br> other condition that could preclude or impair study participation or interfere with<br> study assessments.<br><br> - Has a history of malignant hyperthermia or glucose-6-phosphate dehydrogenase<br> deficiency.<br><br> - Has history or evidence of impaired liver function (e.g., alanine aminotransferase<br> [ALT] > 3 × upper limit of normal [ULN] or total bilirubin > 2 × ULN), active<br> hepatic disease, or cirrhosis.<br><br> - Has history or evidence of impaired renal function (e.g., creatinine > 1.5 × ULN).<br><br> - Has a history of malignancy in the past year<br><br> - Has known or suspected daily use of opioids for 7 or more consecutive days within<br> the previous 6 months
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cumulative Pain Score
- Secondary Outcome Measures
Name Time Method