Recruiting

Duloxetine

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT06423716

Conditions

Knee Osteoarthritis

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Duloxetine

Placebo

Study Details

Brief 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.

Conditions

Knee Osteoarthritis

Study ID

NCT06423716

Start date

Nov 1, 2024

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age >=50
2. Presence of knee osteoarthritis
3. Planned for elective unilateral total knee arthroplasty
4. ASA I - III
5. 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.

Exclusion Criteria:

1. Lack of patient consent; unlikely to comply with follow-up
2. Presence of contraindications to study drug use:

  • Known hypersensitivity to the drug or components of the product
  • Known liver disease - history of cirrhosis, non-alcoholic steatohepatitis
  • Uncontrolled narrow - angle glaucoma
  • Severe renal impairment (CrCl<30mL/min)
  • Concurrent use of thioridazine
  • Concurrent use of potent CYP1A2 inhibitors (e.g. fluvoxamine) and some quinolone antibiotics (e.g. ciprofloxacin or enoxacin)
  • Concurrent use of antidepressants (e.g. MAOI, SSRI, SNRI, TCA, St. John's Wort, buspirone)
  • Concurrent use of triptan or lithium
3. Chronic and high dose opioid use (\&gt;30mg oral morphine equivalent per day)
4. Substance use disorder (cannabis and related products, alcohol use disorder, opioid used disorder, illicit drugs)
5. Uncontrolled hypertension (systolic BP \&gt; 180mmHg)
6. Untreated psychiatric illness (e.g. depression, suicidal ideation, bipolar disorder)
7. Involved in worker's compensation case/law suit (verbally declared by patient)

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

Interventions

Duloxetine

60mg duloxetine given 2 weeks prior to total knee arthroplasty and continued for 6 weeks after surgery.

Placebo

Placebo given 2 weeks prior to total knee arthroplasty and continued for 6 weeks after surgery.

Primary outcome measure

  • Opioid consumption [ Time Frame: Cumulative opioid consumption at 1 week post-operatively ]

Central Contacts and Locations

Central contacts

Howard Meng, MD

416-480-4864howard.meng@sunnybrook.ca

Stephen Choi

416-480 -4864stephen.choi@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Lilia Kaustov, PhD

416-480-6100lilia.kaustov@sunnybrook.ca

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Howard Meng, MD

416-480-4864howard.meng@sunnybrook.ca

Principal Investigator:

Howard Meng, MD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Keywords

  • total knee arthroplasty
  • duloxetine
  • postoperative pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-08-12.