Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Total knee replacement, also known as total knee arthroplasty (TKA), is a surgical procedure aimed at alleviating pain and improving joint function in individuals with severe knee joint damage, often caused by conditions like osteoarthritis (OA) While TKAs generally yield positive results, a significant amount of patients express dissatisfaction with their outcomes, with some continuing to experience persistent pain after surgery. Opioids are very commonly prescribed for postsurgical pan, but they can cause a host of unwanted side effects. Orthopaedic surgeons prescribe opioids more frequently than in any other surgical speciality. This is a rising concern to the healthcare system as it may promote the development of opioid use disorder. There is a need for alternative therapies to opioid prescribing in patients having knee surgery to reduce the extensive health risks associated with opioid medications.

Multiprofen-CC™ is a multimodal topical cream including ingredients ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%). Healthcare professionals have the option to prescribe it to patients who are encountering localized musculoskeletal pain. To date there has been no evidence-based guidance generated to evaluate the efficacy of Multiprofen-CC™ in OA patients although there is compelling evidence that its medicinal ingredients are effective in pain relief.

The aim of the proposed study is to determine if, in patients with end-stage knee OA undergoing TKA, the use of topical Multiprofen-CC™ in addition to standard of care pain management is more effective in reducing acute post-operative pain during a 6 week follow-up period. Secondary objectives include determining the effects of Multiprofen-CC™ compared to placebo on opioid use, satisfaction with pain management, and we will also identify adverse events.

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