Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

Phase 4

Recruiting

• Conditions: THA
• Interventions: Drug: Duloxetine; Other: Placebo

• Registration Number: NCT06807866
• Lead Sponsor: University of Miami

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-29
• Study First Submitted QC: 2025-01-29
• Study First Posted: 2025-02-04
• Status Verified: 2025-03
• Study Start: 2025-03-01
• Last Update Submitted: 2025-03-18
• Last Update Posted: 2025-03-19
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 64

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Duloxetine group	Duloxetine	Participants will be in this group for up to 2 hours.
Placebo group	Placebo	Participants will be in this group for up to 2 hours.

Primary Outcome Measures

Name	Time	Method
Total Milligram Morphine Equivalent (MME)	Up to 24 hours	The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief

Secondary Outcome Measures

Name	Time	Method
Change in Pain as measured by Visual Analog Scale (VAS)	Baseline, up to 24 hours, 3 months	The VAS used for pain assessment consists of a line drawn in the form of a ruler, and numbers from 0 to 10 (with 0 as "no pain" and 10 as "unbearable pain") were asked to score.
Musculoskeletal function as measured by SMFA questionnaire	Up to 3 months	The Short Musculoskeletal Function Assessment Questionnaire (SMFA) consists of 34 questions covering the assessment of the patients function and 12 questions related to how bothered patients are by their symptoms. All categories are scored together, totaling between 0-100 percent. The lower the score, the better the subject's function
Hospital Length of stay measured in hours	Up to 96 hours	Hospital Length of stay measured in hours
Ambulation distance measured by meters	Up to 3 months	Ambulation distance measured by meters

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States