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

Launched by MAJOR EXTREMITY TRAUMA RESEARCH CONSORTIUM · May 27, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of two different pain management methods for people with tibia fractures, which are breaks in the shinbone. In the trial, participants are randomly assigned to one of two groups: one group will receive standard pain management without nonsteroidal anti-inflammatory drugs (NSAIDs), while the other group will receive the same standard pain management but with NSAIDs for up to 6 weeks. The goal is to see how these two approaches compare in terms of healing, pain relief, and the use of opioids, which are stronger pain medications.

To be eligible for the trial, participants should be between 18 and 80 years old and have either an open or closed tibia fracture that is treated with a nail. They also need to be able to attend follow-up visits at the study facility for at least a year after their injury. However, there are some people who cannot participate, such as those with certain health conditions or those who cannot take the study medications. If you join the study, you can expect regular check-ups and support from the research team as you recover from your injury. This trial is currently recruiting participants, and it's a great opportunity to help improve pain management for future patients with similar injuries.

Gender

ALL

Eligibility criteria

• Inclusion 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
• Exclusion Criteria:
• • 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.