Recruiting NCT06807866
Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Duloxetine, Placebo.
- Who it may be relevant to
- Registry conditions: THA. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
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.
Interventions
- Drug Duloxetine
Participants will come in person and receive a one time 60 mg dose by mouth. - Other Placebo
Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.
Primary outcome measures
- Total Milligram Morphine Equivalent (MME) [Time frame: Up to 24 hours]
Secondary outcome measures (4)
- Change in Pain as measured by Visual Analog Scale (VAS) [Time frame: Baseline, up to 24 hours, 3 months]
- Musculoskeletal function as measured by SMFA questionnaire [Time frame: Up to 3 months]
- Hospital Length of stay measured in hours [Time frame: Up to 96 hours]
- Ambulation distance measured by meters [Time frame: Up to 3 months]
Eligibility criteria
Inclusion 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- University of Miami — Miami
Identifiers
NCT: NCT06807866 · 20240579