Effect of peRiopErative duLoxetIne Administration on Opioid Consumption Following Total kneE Arthroplasty (RELIFE)

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age50+
SponsorSunnybrook Health Sciences Centre

About 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

Qualifiers

Age >=50

Presence of knee osteoarthritis

Planned for elective unilateral total knee arthroplasty

ASA I - III

Disqualifiers

Lack of patient consent; unlikely to comply with follow-up

Known hypersensitivity to the drug or components of the product

Known liver disease - history of cirrhosis, non-alcoholic steatohepatitis

Uncontrolled narrow - angle glaucoma

Trial design

Treatments tested in this trial

  • Duloxetine
  • Placebo

Treatment groups

150 Participants
are divided into 2 treatment groups