Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
NCT ID: NCT06807866
Last Updated: 2025-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
64 participants
INTERVENTIONAL
2025-03-01
2026-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty
NCT03271151
Comparison of Opioid and Duloxetine for Postoperative Pain Control After Total Knee Arthroplasty: RCT
NCT04719585
Duloxetine Tibial Plateau
NCT04639011
Postoperative Pain Treatment in Total Hip Arthroplasty: A Study to Assess the Effect of Local Analgesia
NCT00603083
Opioid-Sparing Joint Replacement
NCT07348627
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Duloxetine group
Participants will be in this group for up to 2 hours.
Duloxetine
Participants will come in person and receive a one time 60 mg dose by mouth.
Placebo group
Participants will be in this group for up to 2 hours.
Placebo
Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Duloxetine
Participants will come in person and receive a one time 60 mg dose by mouth.
Placebo
Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients undergoing primary total hip arthroplasty
* Ambulatory patient prior to fracture
* Subjects must be capable of providing informed consent
* English or Spanish speaking
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Miami
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Victor Hugo Hernandez
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Victor Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Miami
Miami, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20240579
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.