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
This trial does not accept healthy volunteersQualifiers
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
Parallel
Treatments tested in this trial
Duloxetine
Drug60mg duloxetine given 2 weeks prior to total knee arthroplasty and continued for 6 weeks after surgery.
Placebo
DrugPlacebo given 2 weeks prior to total knee arthroplasty and continued for 6 weeks after surgery.
Treatment groups
Trial outcomes
Primary outcomes
Opioid consumption
Cumulative opioid consumption at 1 week post-operatively
Secondary outcomes
Nausea/vomiting
Presence of nausea or vomiting
Pain at rest and with activity
Maximum pain score on 0-10 Likert Scale (NRS)
Additional analgesic use
Anti-neuropathic medications
Additional analgesic use: opioid prescription
Family physician or orthopaedic surgeon opioid prescription
Sponsors and contacts
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