Health TrialsbyHealthPanel

Duloxetine for Perioperative Pain in Hip Arthroplasty: A RCT

ConditionTHA
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients > 18 years of age

Patients undergoing primary total hip arthroplasty

Ambulatory patient prior to fracture

Subjects must be capable of providing informed consent

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Duloxetine

    Drug

    Participants will come in person and receive a one time 60 mg dose by mouth.

  • Placebo

    Other intervention

    Participants will come in person and receive a one time 60 mg placebo pill dose by mouth.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Duloxetine groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Total Milligram Morphine Equivalent (MME)

The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief

Time frame
Up to 24 hours

Secondary outcomes

1

Change in Pain as measured by Visual Analog Scale (VAS)

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.

Time frame
Baseline, up to 24 hours, 3 months
2

Musculoskeletal function as measured by SMFA questionnaire

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

Time frame
Up to 3 months
3

Hospital Length of stay measured in hours

Hospital Length of stay measured in hours

Time frame
Up to 96 hours
4

Ambulation distance measured by meters

Ambulation distance measured by meters

Time frame
Up to 3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Source ClinicalTrials.gov
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