Duloxetine RCT on Postop TKA Outcomes
Pain, Postoperative, Total Knee Arthroplasty
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring duloxetine
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)
Sites / Locations
- Rush University medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Duloxetine
Control
Patients randomized to the experimental arm of the study will receive 30 mg of duloxetine and will be advised to consume the medication orally (per os [PO]) daily starting one week prior to surgery and to continue until 6 weeks following surgery. The dose of 30 mg was selected as that has been used as that is the largest starting dose used in other RCTs without requiring a preceding adjustment period at a lower dosage.
Patients randomized to the control arm will receive PO-matched placebo tablets and advised to consume their medication similar to the treatment arm. Both groups of patients will receive their medications from the pharmacy at Rush Medical Center, which will be responsible for providing patients with the appropriate regimen. All patients will receive the same postoperative multimodal analgesic regimen that is normally administered as part of conventional care to patients undergoing TKA at Rush University Medical Center.