Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. 1,000 patients with tibia fractures treated with intramedullary (IM) nail will be randomized into two treatment arms. The control arm will receive standard pain management and no NSAIDs. The treatment arm will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Major Extremity Trauma Research Consortium
• Treatments: Ibuprofen

Criteria

Inclusion Criteria:

• 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 Major Extremity Trauma & Rehabilitation (METRC) facility for at least 12 months following injury

Exclusion Criteria:

• 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 [glomerular filtration rate (GFR):<30]. Patients with moderate renal failure [GFR: 30-59] may participate in the study at a 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 Glasgow Coma Scale (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.