RECRUITING

Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-01

Study Completion:2026-04-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06807866

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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

Inclusion Criteria

Exclusion 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

Contacts and Locations

Study Contact

Victor Hernandez, MD

CONTACT

3056895195

vhh1@miami.edu

Natalia Cruz, MD

CONTACT

3056895195

nxc971@miami.edu

Principal Investigator

Victor Hernandez, MD

PRINCIPAL_INVESTIGATOR

University of Miami

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Collaborators and Investigators

Sponsor: University of Miami

Victor Hernandez, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01

Study Completion Date2026-04-01

Study Record Updates