Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

University of Miami

Status and phase: Enrolling; Phase 4

Conditions: THA

Treatments: Other: Placebo; Drug: Duloxetine

Study type: Interventional

Funder types: Other

Identifiers

NCT06807866

20240579

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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64 participants in 2 patient groups, including a placebo group

Duloxetine group

Experimental group

Description:

Participants will be in this group for up to 2 hours.

Treatment:

Drug: Duloxetine

Placebo group

Placebo Comparator group

Description:

Participants will be in this group for up to 2 hours.

Treatment:

Other: Placebo