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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 below

Select...

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

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor

338 Previous Clinical Trials

75,884 Total Patients Enrolled

Rodolfo Zamora, MDPrincipal InvestigatorUniversity of Louisville

2 Previous Clinical Trials

133 Total Patients Enrolled

Media Library

Trauma Research Study Groups: NSAIDs, Opioids

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment window for this trial restricted to individuals over 40 years of age?

"Individuals aged 18 to 105 are eligible for enrolment in this medical trial."

Answered by AI

What is the current enrollment for this research endeavor?

"Affirmative. According to clinicaltrials.gov, this trial is actively acquiring participants after being first posted on November 12th 2019 and recently updated as of April 15th 2022. The study seeks 100 subjects across two different medical sites."

Answered by AI

Are there any opportunities for volunteers to participate in this research?

"The medical trial is still attempting to enrol participants, as evidenced by the information on clinicaltrials.gov. Originally posted in November of 2019 and last updated in April 2022, this experiment needs volunteers from around the world."

Answered by AI

How does the risk profile of NSAIDs compare to other analgesic medications?

"There is ample evidence that NSAIDs are safe and effective, thus it earned a rating of 3 out of 3."

Answered by AI

What are the eligibility criteria for this research endeavor?

"This trial is currently recruiting 100 individuals aged between 18 and 105 who are suffering from trauma. To qualify, participants must be within the age range stated and have a diaphyseal tibia fracture (OTA/AO 42 A or B)."

Answered by AI

Recent research and studies

Hand ClinicsJournal

Basic Science of Bone Healing

Sathyendra, Vikram, and Michael Darowish. 2013. “Basic Science of Bone Healing”. Hand Clinics. Elsevier BV. doi:10.1016/j.hcl.2013.08.002.

JBJS ReviewsJournal

Nonsteroidal Anti-inflammatory Drugs and Bone-healing

Marquez-Lara, Alejandro, Ian D. Hutchinson, Fiesky Nuñez, Thomas L. Smith, and Anna N. Miller. 2016. “Nonsteroidal Anti-inflammatory Drugs and Bone-healing”. JBJS Reviews. Ovid Technologies (Wolters Kluwer Health). doi:10.2106/jbjs.rvw.o.00055.

Seminars in Cell & Developmental BiologyJournal

Bone Remodeling During Fracture Repair: The Cellular Picture

Schindeler, Aaron, Michelle M. McDonald, Paul Bokko, and David G. Little. 2008. “Bone Remodeling During Fracture Repair: The Cellular Picture”. Seminars in Cell & Developmental Biology. Elsevier BV. doi:10.1016/j.semcdb.2008.07.004.

Journal of Orthopaedic TraumaJournal