Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty
NCT06202989
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 Criteria: * Adults (18+) * Undergoing Primary Elective TKA * Provide informed consent Exclusion Criteria: * 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
Conditions2
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NCT06202989