Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Description

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.

Conditions

THA

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Study Overview

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Study Details

Study overview

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.

Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)

Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Condition
THA
Intervention / Treatment

-

Contacts and Locations

Miami

University of Miami, Miami, Florida, United States, 33136

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Miami,

Victor Hernandez, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

2026-04-01