Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Launched by KAZM PHARMACEUTICALS INC. · Jan 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a topical pain relief treatment called Multiprofen-CC™ for patients who are undergoing total knee replacement surgery, which is done to help people with severe knee arthritis. The goal is to see if using Multiprofen-CC™ along with the usual pain management methods can help control pain better and reduce the need for opioids, which are strong pain medications. Many patients experience ongoing pain after this surgery, and researchers hope that this new treatment can improve their recovery experience.

To participate in the trial, individuals must be at least 18 years old and scheduled for their first total knee replacement surgery. They will need to be able to provide informed consent, meaning they understand the study and agree to take part. Some people may not be eligible, such as those who are pregnant, have certain allergies, or have other health conditions that might interfere with the study. If you join, you can expect to follow a specific treatment plan and report your pain levels during the study to help researchers understand how well the treatment works. This trial is currently recruiting participants, and your involvement could help improve pain management for future knee surgery patients.

Gender

ALL

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