Effect of Perioperative Duloxetine Administration on Opioid Consumption Following Total Knee Arthroplasty

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Age \>=50

• Presence of knee osteoarthritis

• Planned for elective unilateral total knee arthroplasty

• ASA I - III

• Baseline creatinine clearance (CrCl) ≥ 30 mL/min within 60 days prior to enrolment, if available. If not available, verbal report from patient of no known renal disease.

Locations
Other Locations
Canada
Sunnybrook Health Sciences Centre
RECRUITING
Toronto
Contact Information
Primary
Howard Meng, MD
howard.meng@sunnybrook.ca
416-480-4864
Backup
Stephen Choi
stephen.choi@sunnybrook.ca
416-480 -4864
Time Frame
Start Date: 2024-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 150
Treatments
Experimental: Intervention
Duloxetine 60mg OD for 2 weeks preoperatively then 60mg OD for 6 weeks post-surgery.
Placebo_comparator: Control
Placebo OD for 2 weeks preoperatively then OD for 6 weeks post-surgery.
Sponsors
Leads: Sunnybrook Health Sciences Centre

This content was sourced from clinicaltrials.gov