Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial
KAZM Pharmaceuticals Inc.
288 participants
Sep 9, 2024
INTERVENTIONAL
Conditions
Summary
Total knee arthroplasty is a surgical treatment which involves replacing the damaged articular cartilage of the knee joint with an artificial prosthetic in end-stage knee osteoarthritis. Although total knee arthroplasties are mostly successful, approximately 1 in 5 patients are unsatisfied with their outcomes with 16-33% of patients of patients experiencing lasting pain following total knee arthroplasty. Multiprofen-CC™ is a compounded topical analgesic currently available to healthcare professionals for prescription in patients experiencing localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in osteoarthritis patients. This study will test, in patients with end-stage knee osteoarthritis undergoing total knee arthroplasty, if the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in controlling knee pain and reducing opioid use compared to placebo plus standard care alone.
Eligibility
Inclusion Criteria3
- Adults (18+)
- Undergoing Primary Elective TKA
- Provide informed consent
Exclusion Criteria16
- Administration of any investigational drug in the period of 0 to 45 days before entry into the study
- Pregnancy
- Actively breastfeeding
- Unable to provide informed consent (e.g. cognitive disability)
- Unable or unwilling to follow study protocol (e.g. unwilling to apply the topical treatments as instructed)
- Have a known allergy to ketoprofen, other NSAIDs, baclofen, amitriptyline, or lidocaine, any of the study drugs or their ingredients
- Have a history of substance abuse
- Use daily opioids (other than short acting codeine) for a chronic pain condition other than knee OA
- Are undergoing a revision TKA or are scheduled for a simultaneous bilateral TKA
- Any other condition which, in the opinion of the investigators, is likely to interfere with the successful collection of the measures required for the study
- Diagnosis of uncontrolled hypertension
- Diagnosis of active peptic ulcer disease
- A history of chronic (> 3 months) anticoagulant usage
- History of impaired kidney or liver function
- Have open wounds/cuts and/or skin conditions on the knee area, other than the surgical incision
- Body Mass Index (BMI) > 50kg/m2
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Interventions
Multiprofen-CC™ \[ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)\] Dose: 1.0g, 3 times per day for 6 weeks after surgery
The placebo is the base cream with no medicinal ingredients to be applied 3 times per day for 6 weeks after surgery
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06202989