Duloxetine for pain management after knee surgery
A Prospective, Triple-Blind, Randomized Controlled Trial Evaluating Duloxetine on Post-Operative Outcomes Following Primary Total Knee Arthroplasty in Patients With and Without Central Sensitization
This study tests if taking duloxetine can help people manage pain better after knee surgery compared to a placebo.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 504 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Rush University Medical Center Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT05086393 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of duloxetine on postoperative pain, patient-reported outcomes, and opioid consumption in patients undergoing total knee arthroplasty (TKA). It aims to determine if duloxetine can improve pain management compared to a placebo. The study includes patients aged 18 and older who are scheduled for primary TKA due to osteoarthritis. Participants will be randomly assigned to receive either duloxetine or a placebo, with outcomes measured over a specified period post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 undergoing primary total knee arthroplasty for osteoarthritis.
Not a fit: Patients with significant psychiatric disorders, prior use of certain medications, or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management and reduced opioid use for patients recovering from knee surgery.
How similar studies have performed: Previous studies have shown that duloxetine can effectively reduce postoperative pain and opioid consumption, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Any patient undergoing primary total knee arthroplasty for osteoarthritis * Age ≥ 18 years old * Willingness to undergo randomization and return for all scheduled visits * English speaking Exclusion Criteria: * Age \> 80 years old * American Society of Anesthesiologists (ASA) Score ≥ 4 * Prior use of SSRIs or SNRIs * Use of serotonergic drugs in the past 6 months with the exception of tramadol * Known psychiatric disorder (specifically: generalized anxiety disorder, major depressive disorder, type I or type II bipolar disorder, and schizophrenia) * Heavy alcohol consumption defined as ≥ 14 drinks per week for men and ≥ 7 drinks per week for women * Opioid tolerant patients defined as ≥ 60 morphine equivalents (MEQs) per day within 90 days prior to surgery * Renal impairment defined as a glomerular filtration rate (GFR) \< 30 mL/minute or creatinine \>1.3 mg/dL * Non-English speaking * Non-independent (i.e. requires a caretaker to make medical decisions on their behalf)
Where this trial is running
Chicago, Illinois
- Rush University medical Center — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Denis Nam, MD, MSc
- Email: denis.nam@rushortho.com
- Phone: (312)432-2468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.