Duloxetine for Pain After Hip Replacement

This study is testing whether a single dose of duloxetine can help reduce the amount of strong pain medication (narcotics) needed after a total hip replacement (THA). You might be able to join if you are over 18, having your first total hip replacement on one side, can walk before your surgery, and can understand English or Spanish. The study aims to see if duloxetine leads to less narcotic use compared to a placebo (an inactive pill). The current recruitment status is unclear.

Study design
This is an interventional study planning to enroll 64 participants. It compares duloxetine to a placebo.
What's involved
Participants will come in person to receive a one-time 60 mg dose of either duloxetine or a placebo pill by mouth.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, total narcotic intake, is measured up to 24 hours after the dose.

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NCT06807866

Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Recruiting
PHASE4Ages 18+InterventionalSupportive care
University of Miami
~64 participants
Updated 2026-03-18 on ClinicalTrials.gov
What's tested:DuloxetinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Total Milligram Morphine Equivalent (MME)
Measured over Up to 24 hours
THA
1 sites across 1 states
Florida1
  • Victor Hernandez, MD · PRINCIPAL_INVESTIGATOR · University of Miami

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Eligibility criteria

Inclusion

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

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
  • Total Milligram Morphine Equivalent (MME)Up to 24 hours

    The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief