Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
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.
  • Drug: 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 names:
    • Advil
    • Motrin
No Intervention
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.

Recruiting Locations

The MetroHealth System
Cleveland, Ohio 44109

More Details

Status
Recruiting
Sponsor
Major Extremity Trauma Research Consortium

Study Contact

Thomas Higgins, MD
801-870-113
thomas.higgins@hsc.utah.edu

Detailed Description

The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase III noninferiority trial. We will randomize patients with diaphyseal tibia fractures treated with intramedullary (IM) nail into two treatment arms. The control group will receive standard pain management with no NSAIDs. The treatment intervention group will receive standard pain management plus up to six weeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN). Our hypothesis is that pain management using up to 6 weeks of NSAIDs will result in improved pain control and lower opioid consumption but demonstrate non-inferior levels of complications compared to standard of care pain management. The aim of the study is to: 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.