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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)
Must not have
-Tibial fractures not treated with intramedullary nails
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 1 year
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Approved for 10 Other Conditions
Pivotal Trial
Drug Has Already Been Approved

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.
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.
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 below
Select...
I am between 18 and 105 years old.
Select...
I have a specific type of shinbone fracture.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My broken shinbone was not fixed using a metal rod inside the bone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Time to union

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

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
347 Previous Clinical Trials
77,501 Total Patients Enrolled
Rodolfo Zamora, MDPrincipal InvestigatorUniversity of Louisville
3 Previous Clinical Trials
283 Total Patients Enrolled

Media Library

Trauma Research Study Groups: NSAIDs, Opioids
~17 spots leftby Nov 2025
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