Effect of NSAIDs on Union, Opioid Utilization and Pain Management for Tibia Fractures
K
Karl Shively
Primary Investigator
B
Brian Mullis, MD
Primary Investigator
Enrolling By Invitation
18-80 years
All
Phase
3
1000 participants needed
2 Locations
Brief description of study
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase IIIy trial. 1,000 patients with tibia fractures treated with intramedullary (IM)will be randomized into two treatment arms. The control arm will receive standard paingement and no NSAIDs. The treatment arm will receive standard pain management plus up toweeks of NSAIDs (3 weeks of prescribed medication followed by 3 weeks of medication PRN).
Detailed description of study
The proposed study is a two arm, pragmatic, randomized controlled multicenter Phase IIIy trial. Patients with diaphyseal tibia fractures treated with intramedullary
(IM) nail will be randomized into two treatment arms. The control arm will receive standardgement with 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).
The hypothesis is that pain management using up to 6 weeks of NSAIDs will result in improvedd lower opioid consumption but demonstrate non-inferior levels ofd 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.dard pain management plus up to 6 weeks of NSAIDs (Group 2) in the treatment of tibialhaft fractures.
Primary Hypothesis: When compared to patients who received standard of care pain management,d with up to 6 weeks of NSAIDs will have noninferior rates of surgery for tounion 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) reducedd utilization; (2) reduced levels of persistent pain; (3) reduced pain interference; (4)ved functional outcomes; (5) noninferior rates of analgesic treatment related side; and (6) noninferior rates of radiographic union.
Study design: At time of IM nailing surgery for acute diaphyseal tibia fracture, patients
will be randomized to treatment or control group. Treatment patients will receive a standardgimen and oral ibuprofen 600 mg three times a day (tid) for up to six weeks (3
weeks of prescribed medication followed by 3 weeks of medication PRN). Control patients willve a standard of care pain regimen prescribed by the treating physician and may not useAIDs. Patients in both arms will be permitted to receive 81mg of daily aspirin. Patientdication adherence will be documented via an electronic data collection interface throughbile or web-based application. Patients who do not have access to documenting adherencey will be given paper-based medication dairies by the research team.
Follow-Up: Clinical, functional, and radiographic follow-up will be conducted at typicaldard of care intervals of 2-3 weeks, 6 weeks, 3 months, 6 months, and one year.
Study duration: 3.75 years (18 month accrual, 24 month final follow-up, 3 month analysis and
writing).
Sample size: 1,000 (500 per arm (2) arms)
Number of study sites: 14 sites (13 Civilian and 1 Military Treatment Facility)
Study population: The study population will consist of a relatively homogeneous group of
1,000 patients with orthopaedic trauma: patients with open or closed diaphyseal tibiaures. Since military combat injuries are typically open, open fractures will be includedhis study. However, since post-surgical pain after these injuries is not limited to theures, and the practices of pain management should apply to both open and closedjuries, closed versions of these high energy injuries in the study population will also beuded.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Tibia Fracture
-
Age: Between 18 Years - 80 Years
-
Gender: All
Inclusion Criteria:
- All patients with open (Grade I, II, of IIIa) or closed tibia fractures treated with a.
- Patients 18-80 years old inclusive.
- Patients able to be followed at a Major Extremity Trauma & Rehabilitation (METRC)y 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]. Patientswith moderate renal failure [GFR: 30-59] may participate in the study at a modifieddose.
- Patients undergoing daily treatment with systemic glucocorticoids before surgery.
- Patients likely to have severe problems maintaining follow-up, including patientsdiagnosed with a severe psychiatric conditions, patients who live too far outside thehospital's catchment area, patients who are incarcerated and patients who haveunstable 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 initialdefinitive fixation surgery.
Updated on
01 Aug 2024.
Study ID: W81XWH2020063
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