RECRUITING

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Description

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Conditions

Tibial FracturesPain
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Related Conditions:

Tibial FracturesPain

Study Overview

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Study Details

Study overview

Two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial evaluating the efficacy of standard pain management without NSAIDs (Group 1) vs. standard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibial shaft fractures.

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial

Condition
Tibial Fractures
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Eskenazi Hospital, Indianapolis, Indiana, United States, 46202

Indianapolis

Indiana University-Methodist, Indianapolis, Indiana, United States, 46202

Baltimore

University of Maryland R Adams Cowley Shock Trauma Center, Baltimore, Maryland, United States, 21201

Cambridge

Harvard Medical Center, Cambridge, Massachusetts, United States, 02138

Minneapolis

Hennepin Health, Minneapolis, Minnesota, United States, 55487

Jackson

University of Mississippi, Jackson, Mississippi, United States, 39216

Cleveland

The MetroHealth System, Cleveland, Ohio, United States, 44109

Pittsburgh

Allegheny General Hospital, Pittsburgh, Pennsylvania, United States, 15212

Nashville

Vanderbilt Medical Center, Nashville, Tennessee, United States, 37203

Houston

University of Texas Health Science Center - Houston, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
  • 2. Patients 18-80 years old inclusive.
  • 3. Patients able to be followed at a METRC facility for at least 12 months following injury
  • 1. Patient unable to provide informed consent
  • 2. Patients who are current - intravenous drug user.
  • 3. Patients with a history of allergy to the study drugs.
  • 4. Patients unable to swallow oral medications or without functioning GI tract.
  • 5. Patients with a history of gastrointestinal bleeds or gastric perforation.
  • 6. Patients with a history of stroke or heart attack.
  • 7. Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
  • 8. Patients with any bleeding disorders.
  • 9. Patients with severe renal failure \[GFR:\<30\]. Patients with moderate renal failure \[GFR: 30-59\] may participate in the study at a modified dose \[see section 8.6 for defined modified dose\].
  • 10. Patients undergoing daily treatment with systemic glucocorticoids before surgery.
  • 11. Patients likely to have severe problems maintaining follow-up, including patients diagnosed with a severe psychiatric conditions, patients who live too far outside the hospital's catchment area, patients who are incarcerated and patients who have unstable housing situations.
  • 12. Patients with a GCS \<15 at discharge.
  • 13. Patients with a closed head injury that precludes NSAIDS.
  • 14. Patients who are pregnant or lactating at time of screening
  • 15. Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Major Extremity Trauma Research Consortium,

Thomas Higgins, MD, PRINCIPAL_INVESTIGATOR, University of Utah

Renan Castillo, PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

2027-03