Duloxetine for Osteoarthritis

(RELIFE Trial)

Overseen By Sebastian Tomescu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Sunnybrook Health Sciences Centre

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

Knee replacement surgery for osteoarthritis is a commonly performed procedure in Canada with 75,000 of these surgeries performed each year. Success rate for knee replacement surgery is high but more than 20% of patients are still dissatisfied mainly due to reports of ongoing pain. Pain control following knee surgery is important in order to allow patients to engage in recovery and rehabilitation. The current standard of pain management after surgery centers around the use of opioids which is a concerning practice as highlighted by the opioid epidemic. Duloxetine is an antidepressant that has pain relieving properties and it has been studied in patients undergoing knee replacement surgery. Studies to date have not been designed optimally to demonstrate the full effects of opioid dose reduction and the use of duloxetine as a medication following knee replacement surgery. This research study seeks to start duloxetine before surgery, at the recommended therapeutic dose, and for the duration of the early rehabilitation period. If the study is successful, this low-cost medication can improve satisfaction rates and change the standard way the pain management is typically carried out for patients undergoing the knee replacement surgery.

Eligibility Criteria

The RELIFE trial is for individuals with osteoarthritis undergoing total knee replacement surgery. Participants should not have used opioids or antidepressants recently, and must be able to take oral medication. They are excluded if they have chronic pain disorders other than osteoarthritis, a history of substance abuse, or conditions that interfere with the study.

Inclusion Criteria

I have knee osteoarthritis.

I am scheduled for knee replacement surgery on one knee.

I am 50 years old or older.

Exclusion Criteria

Involved in worker's compensation case/law suit (verbally declared by patient)

My blood pressure is not higher than 180mmHg.

I am currently taking triptan or lithium.

Treatment Details

Interventions

• Duloxetine (Antidepressant)

Trial Overview This trial tests whether taking Duloxetine (an antidepressant with pain-relieving properties) before and after knee replacement surgery can reduce the need for opioids during recovery compared to a placebo. The goal is to improve post-surgery satisfaction by optimizing pain management.

Participant Groups

Group I: Intervention Experimental Treatment 1 Intervention

Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery.

Group II: Control Placebo Group 1 Intervention

Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery.

Duloxetine is already approved in Canada for the following indications:

Approved in Canada as Cymbalta for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Fibromyalgia
• Neuropathic Pain
• Chronic Musculoskeletal Pain

Who Is Running the Clinical Trial?

Sunnybrook Health Sciences Centre

Lead Sponsor

Trials

693

Recruited

1,569,000+