Duloxetine RCT on Postop TKA Outcomes

• Status: Not yet recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is to determine if duloxetine is associated with differences in post-operative pain, patient-reported outcome measures, and opioid consumption in patients undergoing primary total knee arthroplasty compared to patients who do not receive the medication. If so, duloxetine has the potential to become widely incorporated into the multi-modal analgesic regimen given to patients following knee replacements.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: Duloxetine Hydrochloride

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)