Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures: A Pragmatic, Randomized Controlled Trial
NCT ID: NCT07006675
Last Updated: 2025-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1000 participants
INTERVENTIONAL
2021-05-26
2027-03-31
Brief Summary
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Detailed Description
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Specific Aim: Evaluate the effect 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.
Primary Hypothesis: When compared to patients who received standard of care pain management, patients treated with up to 6 weeks of NSAIDs will have noninferior rates of surgery for nonunion at one year.
Secondary Hypotheses: When compared to patients who received standard of care pain management without NSAIDs, patients treated with up to 6 weeks of NSAIDs will benefit from (1) reduced opioid utilization; (2) reduced levels of persistent pain; (3) reduced pain interference; (4) improved functional outcomes; (5) noninferior rates of analgesic treatment related side effects; and (6) noninferior rates of radiographic union.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Standard of Care Pain Management with NSAIDs
Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.
600 mg Ibuprofen
Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.
Standard of Care Pain Management without NSAIDs
Control patients will receive standard of care pain medication regimen and may not use NSAIDs. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs.
No interventions assigned to this group
Interventions
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600 mg Ibuprofen
Treatment patients will receive oral ibuprofen 600 mg three times a day (tid) for up to six weeks. Clinicians in this group may use whatever further analgesia they desire, excluding NSAIDs. For patients who have a clinical concern regarding NSAID and prophylactic anticoagulation, the treating physician may consider prescribing misoprostol.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients 18-80 years old inclusive.
3. Patients able to be followed at a METRC facility for at least 12 months following injury
Exclusion Criteria
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.
18 Years
80 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Major Extremity Trauma Research Consortium
OTHER
Responsible Party
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Principal Investigators
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Thomas Higgins, MD
Role: PRINCIPAL_INVESTIGATOR
University of Utah
Renan Castillo, PhD
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Eskenazi Hospital
Indianapolis, Indiana, United States
Indiana University-Methodist
Indianapolis, Indiana, United States
University of Maryland R Adams Cowley Shock Trauma Center
Baltimore, Maryland, United States
Harvard Medical Center
Cambridge, Massachusetts, United States
Hennepin Health
Minneapolis, Minnesota, United States
University of Mississippi
Jackson, Mississippi, United States
The MetroHealth System
Cleveland, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
University of Texas Health Science Center - Houston
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
University of Calgary, Foothills Medical Centre
Calgary, Alberta, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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W81XWH-15-2-0058
Identifier Type: -
Identifier Source: org_study_id
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