Duloxetine RCT on Postop TKA Outcomes

Launched by RUSH UNIVERSITY MEDICAL CENTER · Oct 19, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called duloxetine on patients who are having total knee replacement surgery, specifically looking at how it affects pain, recovery, and the need for opioid painkillers after the surgery. Researchers want to see if taking duloxetine can help patients feel less pain and improve their overall recovery experience compared to those who do not take the medication. This could lead to duloxetine being included as part of the standard pain management plan for patients after knee surgery.

To participate in this trial, you need to be at least 18 years old and be scheduled for a total knee replacement due to arthritis. You should be able to speak English and be willing to attend all follow-up visits. However, if you are over 80 years old, have certain medical conditions, or have taken specific medications recently, you may not qualify for the study. If you decide to join, you'll be randomly assigned to either receive duloxetine or a placebo (a non-active pill) and will be monitored closely during your recovery. This trial is currently recruiting participants, and your involvement could help improve pain management for future patients undergoing knee replacement surgery.

Gender

ALL

Eligibility 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)