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

Recruiting now · Phase 3

Conditions studied: Tibial Fractures, Pain

In brief

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.

Key facts

Study ID: NCT07006675
Run by: Major Extremity Trauma Research Consortium
People needed: 1000
Starts: 2021-05-26
Expected to finish: 2027-03-01
Last updated by the study team: 2025-06-05

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a nail.
Patients 18-80 years old inclusive.
Patients able to be followed at a METRC facility for at least 12 months following injury

You may not qualify if…

Patient unable to provide informed consent
Patients who are current - intravenous drug user.
Patients with a history of allergy to the study drugs.
Patients unable to swallow oral medications or without functioning GI tract.
Patients with a history of gastrointestinal bleeds or gastric perforation.
Patients with a history of stroke or heart attack.
Patients requiring an aspirin or NSAID regimen except for low dose aspirin, 81mg.
Patients with any bleeding disorders.
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].
Patients undergoing daily treatment with systemic glucocorticoids before surgery.
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.
Patients with a GCS <15 at discharge.
Patients with a closed head injury that precludes NSAIDS.
Patients who are pregnant or lactating at time of screening
Patients with a bone graft procedure planned for a future date at the time of initial definitive fixation surgery.

Where it is running

Eskenazi Hospital — Indianapolis, Indiana, United States (enrolling)
Indiana University-Methodist — Indianapolis, Indiana, United States (enrolling)
University of Maryland R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States (enrolling)
Harvard Medical Center — Cambridge, Massachusetts, United States (enrolling)
Hennepin Health — Minneapolis, Minnesota, United States (enrolling)
University of Mississippi — Jackson, Mississippi, United States (enrolling)
The MetroHealth System — Cleveland, Ohio, United States (enrolling)
Allegheny General Hospital — Pittsburgh, Pennsylvania, United States (enrolling)
Vanderbilt Medical Center — Nashville, Tennessee, United States (enrolling)
University of Texas Health Science Center - Houston — Houston, Texas, United States (enrolling)
University of Utah — Salt Lake City, Utah, United States (enrolling)
Inova Fairfax Hospital — Falls Church, Virginia, United States (enrolling)
University of Wisconsin — Madison, Wisconsin, United States (enrolling)
University of Calgary, Foothills Medical Centre — Calgary, Alberta, Canada (enrolling)

Full record on ClinicalTrials.gov

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