Using Multiprofen-CC™ to manage pain after knee replacement surgery

Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty: A Blinded Randomized Controlled Trial

This study is testing if a new topical pain relief treatment called Multiprofen-CC™ can help people feel less pain after knee replacement surgery and reduce their need for opioids.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 288 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: KAZM Pharmaceuticals Inc. (industry)
• Locations: 2 sites (Hamilton, Ontario and 1 other locations)
• Trial ID: NCT06202989 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Multiprofen-CC™, a topical analgesic, in reducing postsurgical pain and opioid use in patients undergoing total knee arthroplasty due to end-stage knee osteoarthritis. Participants will receive either Multiprofen-CC™ combined with standard pain management or a placebo with standard care. The study aims to provide evidence-based guidance on the efficacy of this treatment in improving patient outcomes and minimizing reliance on opioids. By comparing the two groups, researchers hope to determine if the topical treatment offers significant pain relief.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are scheduled for primary elective total knee arthroplasty.

Not a fit: Patients with a history of substance abuse or those currently using daily opioids for chronic pain unrelated to knee osteoarthritis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce postsurgical pain and opioid consumption for knee replacement patients.

How similar studies have performed: While there is limited evidence specifically for Multiprofen-CC™, similar multimodal approaches have shown promise in managing postsurgical pain in other contexts.

Eligibility criteria

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

Where this trial is running

Hamilton, Ontario and 1 other locations

• St. Joseph's Healthcare Hamilton — Hamilton, Ontario, Canada (RECRUITING)
• Oakville Trafalgar Memorial Hospital — Oakville, Ontario, Canada (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Giuseppe Valente, MD, MMgt, FRCSC — McMaster University
• Study coordinator: Breanne Flood, MSc

Conditions: Postsurgical Pain, Osteoarthritis, Knee, Arthroplasty, Replacement, Knee, Analgesics, Opioid