RecruitingPhase 4NCT06807866
Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
Sponsor
University of Miami
Enrollment
64 participants
Start Date
Mar 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- Patients > 18 years of age
- Patients undergoing primary total hip arthroplasty
- Ambulatory patient prior to fracture
- Subjects must be capable of providing informed consent
- English or Spanish speaking
Exclusion Criteria14
- Previous hemiarthroplasty or THA on ipsilateral hip
- History of Complex Regional Pain Syndrome in ipsilateral extremity
- History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
- Acute or chronic hip infection in ipsilateral extremity
- Pregnant or breastfeeding
- Open fracture
- Polytrauma
- Intravenous or drug users within 6 months of surgery
- Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
- Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
- Severe renal dysfunctions, such as glomerular filtration rate less than 30
- Moderate to severe depression as diagnosed by a clinician
- Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
- History of uncontrolled narrow angle glaucoma
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Interventions
DRUGDuloxetine
Participants will come in person and receive a one time 60 mg dose by mouth.
OTHERPlacebo
Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06807866