Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
- Conditions
- Postsurgical Pain
- Registration Number
- NCT06202989
- Lead Sponsor
- KAZM Pharmaceuticals Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- All
- Target Recruitment
- 288
Inclusion Criteria:<br><br> - Adults (18+)<br><br> - Undergoing Primary Elective TKA<br><br> - Provide informed consent<br><br>Exclusion Criteria:<br><br> - Administration of any investigational drug in the period of 0 to 45 days before<br> entry into the study<br><br> - Pregnancy<br><br> - Actively breastfeeding<br><br> - Unable to provide informed consent (e.g. cognitive disability)<br><br> - Unable or unwilling to follow study protocol (e.g. unwilling to apply the topical<br> treatments as instructed)<br><br> - Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, or<br> lidocaine, any of the study drugs or their ingredients<br><br> - Have a history of substance abuse<br><br> - Use daily opioids (other than short acting codeine) for a chronic pain condition<br> other than knee OA<br><br> - Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA<br><br> - Any other condition which, in the opinion of the investigators, is likely to<br> interfere with the successful collection of the measures required for the study<br><br> - Diagnosis of uncontrolled hypertension<br><br> - Diagnosis of active peptic ulcer disease<br><br> - A history of chronic (> 3 months) anticoagulant usage<br><br> - History of impaired kidney or liver function<br><br> - Have open wounds/cuts and/or skin conditions on the knee area, other than the<br> surgical incision<br><br> - Body Mass Index (BMI) > 50kg/m2
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Acute postoperative pain
- Secondary Outcome Measures
Name Time Method Time to opioid cessation;Satisfaction with Pain Management;Safety - Adverse events;Cumulative opioid use measured in Morphine Equivalent Dose (MED)