Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT05086393
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)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT05086393
Study Brief:
Protocol Section:
NCT05086393