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Nonsteroidal Anti-inflammatory Drug
Pain Management for Trauma Recovery
Phase 4
Recruiting
Led By Rodolfo Zamora, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients between the ages of 18 and 105
Diaphyseal tibia fracture (OTA/AO 42 A, B)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
Study Summary
This trial will compare the effects of two different pain management methods on patients recovering from surgery.
Who is the study for?
This trial is for individuals aged 18 to 105 who have a specific type of tibia fracture (OTA/AO 42 A, B) and are receiving intramedullary nails as treatment. Those with different types of tibial fractures not treated this way cannot participate.Check my eligibility
What is being tested?
The study compares the effectiveness and pain management between two groups: one taking only opioids, and another using NSAIDs combined with a reduced dose of opioids after surgery for tibia fractures.See study design
What are the potential side effects?
NSAIDs may cause stomach upset, bleeding, kidney problems or increased blood pressure. Opioids can lead to constipation, nausea, drowsiness, addiction risk and respiratory depression.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 105 years old.
Select...
I have a specific type of shinbone fracture.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to union
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: NSAIDsExperimental Treatment1 Intervention
This arm is given NSAIDs perioperatively and after discharge
Group II: OpioidsActive Control1 Intervention
This arm will be given the standard opioids treatment to control pain perioperatively and at discharge.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen
FDA approved
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
339 Previous Clinical Trials
76,580 Total Patients Enrolled
Rodolfo Zamora, MDPrincipal InvestigatorUniversity of Louisville
2 Previous Clinical Trials
133 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: NSAIDs
- Group 2: Opioids
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