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Duloxetine for Pain in Total Hip Arthroplasty
Miami, FL
Phase 4
Waitlist Available
Led By Victor Hernandez, MD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients undergoing primary total hip arthroplasty
Ambulatory patient prior to fracture
Must not have
Previous hemiarthroplasty or THA on ipsilateral hip
History of Complex Regional Pain Syndrome in ipsilateral extremity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, up to 24 hours, 3 months
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to compare the amount of pain medication taken by patients who receive duloxetine versus those who receive a placebo after hip replacement surgery.
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Who is the study for?
This trial is for English or Spanish speaking adults over 18 who can consent and are having a primary total hip arthroplasty. They must have been able to walk before surgery. It's not for those with severe depression, glaucoma, hip infections, certain drug histories, liver failure, severe kidney issues, or taking specific antidepressants.Check my eligibility
What is being tested?
The study tests if Duloxetine reduces the need for narcotics after hip replacement surgery compared to a placebo. Participants will be randomly assigned to receive either Duloxetine or an inactive pill to assess pain management effectiveness.See study design
What are the potential side effects?
Duloxetine may cause side effects like nausea, dry mouth, sleepiness, constipation and sweating more than usual. It might also affect sexual function and could lead to increased blood pressure in some cases.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am having my first total hip replacement surgery.
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I was able to walk on my own before my fracture.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had hip surgery on the same side before.
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I have had Complex Regional Pain Syndrome in the same side limb.
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Select...
I have uncontrolled narrow angle glaucoma.
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I have a hip infection in the same side of my body.
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I have a broken bone that is exposed through my skin.
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I have not used intravenous drugs in the last 6 months.
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I have liver failure or my blood clotting tests are abnormal.
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My kidney function is severely impaired.
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I have been diagnosed with moderate to severe depression.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, up to 24 hours, 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, up to 24 hours, 3 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Total Milligram Morphine Equivalent (MME)
Secondary study objectives
Ambulation distance measured by meters
Change in Pain as measured by Visual Analog Scale (VAS)
Hospital Length of stay measured in hours
+1 moreSide effects data
From 2012 Phase 4 trial • 291 Patients • NCT0111878011%
Nausea
11%
Headache
9%
Constipation
8%
Dizziness
7%
Dry mouth
6%
Somnolence
5%
Diarrhoea
4%
Abdominal pain upper
4%
Fall
4%
Decreased appetite
4%
Pruritus
3%
Vertigo
3%
Hyperhidrosis
2%
Nasopharyngitis
1%
Hypertensive crisis
1%
Angina pectoris
1%
Back pain
1%
Insomnia
1%
Large intestinal obstruction
100%
80%
60%
40%
20%
0%
Study treatment Arm
Duloxetine
Placebo
Awards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Duloxetine groupExperimental Treatment1 Intervention
Participants will be in this group for up to 2 hours.
Group II: Placebo groupPlacebo Group1 Intervention
Participants will be in this group for up to 2 hours.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Duloxetine
2011
Completed Phase 4
~4170
Find a Location
Closest Location:University of Miami· Miami, FL· 995 miles
Who is running the clinical trial?
University of MiamiLead Sponsor
974 Previous Clinical Trials
423,461 Total Patients Enrolled
Victor Hernandez, MDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
5,478 Total Patients Enrolled