Multiprofen-CC™ to Reduce Pain After Total Knee Arthroplasty

Postsurgical Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06202989
• Other study ID #: PR-001.2
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 2024
• Est. completion date: April 1, 2025

Study information

• Verified date: January 2024
• Source: KAZM Pharmaceuticals Inc.
• Contact: Kim Madden, PhD
• Phone: 289-237-7380
• Email: maddenk[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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 controlling knee pain and reducing opioid use compared to placebo plus standard care alone during a 3 month follow-up period. Secondary objectives include determining the effects of Multiprofen-CC™ compared to placebo on health-related quality of life and satisfaction with pain management, and we will also identify adverse events.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 326
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults (18+)

• Undergoing Primary Elective TKA

• Provide informed consent

Exclusion Criteria:

• Unable to consent

• Unable or unwilling to follow study protocol

• Known allergy or contraindication to any of the study drugs or their ingredients

• Use of daily opioids (with the exception of short acting codeine, i.e. Tylenol #3)

• Have open wounds/cuts and/or skin conditions on the knee area, other than the surgical incision

• Pregnant or breastfeeding

• History of impaired kidney or liver function

• Simultaneous bilateral TKA

• Uncontrolled hypertension

• Active peptic ulcer disease

• Chronic (> 3months) of anticoagulant use

Related Conditions & MeSH terms

• Pain, Postoperative
• Postsurgical Pain

Intervention

Drug:
• Multiprofen-CC™ plus standard treatment
Multiprofen-CC™ [ketoprofen (10%), baclofen (5%), amitriptyline (2%), and lidocaine (5%)] Dose: 1.0g, 3 times per day for 3 months after surgery

Other:
• Placebo plus standard treatment
The placebo is the base cream with no medicinal ingredients

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario
Canada	Oakville Trafalgar Memorial Hospital	Oakville	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
KAZM Pharmaceuticals Inc.	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cumulative Opioid Use	Use of opioids (mean morphine equivalent dose [MED] change)	up to 3 months postop
Secondary	Time to opioid cessation	Time to opioid cessation	3 months postop
Secondary	Health-related Quality of Life	Health-related quality of life measured on EuroQol 5 Dimensions (EQ-5D)	6 weeks and 3 months postop
Secondary	Satisfaction with Pain Management	Satisfaction with pain management measured on a 0-10 numeric rating scale (NRS; higher score is better)	3 months postop
Secondary	Safety - Adverse events	Serious and non-serious adverse events	up to 3 months postop