Pilon Fracture | Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)
Pilon Fracture research study
What is the primary objective of this study?
The purpose of this study is to definitively resolve questions regarding the use of multimodal pharmacologic pain management for orthopedic trauma patients in the context of a multicenter, randomized clinical trial. Also, as a significant proportion of this population develops chronic post traumatic osteoarthritis (PTOA), a sub-objective of this study is to examine the etiology and incidence of chronic pain and PTOA in this population.
Who is eligible to participate?
Inclusion Criteria: 1. Patients with one of the following types of injuries: 1. Unilateral, Grade I or 2. Unilateral, open (type I, II, or IIIA) ankle fractures with associated dislocation on presentation (OTA 44B3 or 44C) requiring operative treatment with fixation; or 3. Unilateral, open or closed distal and proximal humerus (OTA 11A-C and OTA 13 A-C); or 4. Open femoral shaft fracture (OTA 32 A-C; Gustilo Type I-IIIC) or open or closed supracondylar femur fractures (OTA 33 A-C); or 5. Open or closed tibial plateau or shaft fractures (OTA 42 A-C or 43 A-C) 6. Any combination of the above injuries which are surgically treated as a whole 2. Patients who present to the admitting hospital acutely or clinic following an initial assessment in the Emergency Department, for care up to 10 days following initial injury. 3. Patients 18-80 years old inclusive. 4. Patients who are English or Spanish competent. 5. Treating physicians agree that none of the study drugs are indicated for standard of care treatment for this patient. 6. Patients able to be followed at the METRC facility for at least 12 months following injury. Exclusion Criteria: 1. Patients unable to provide informed consent. 2. Patients with chronic pain being presently treated with opioid or gabapentinoid prescription or any other alternative therapy. 3. Patients who are current IVDA 4. Patients with bilateral or ipsilateral injuries requiring surgery 5. Patients with other orthopedic or non-orthopedic injuries requiring operative intervention 6. Patients with severe osteopenia. 7. Patients who are skeletally immature (defined as less than 18 years of age or no radiographic evidence of epiphyseal closure). 8. Patients who are expected to have a post-surgical stay less than 24 hours. 9. Patients with a history of allergy to any drugs in the study. 10. Patients unable to swallow oral medications or without adequately functioning GI tract. 11. Patients with a history of gastrointestinal bleeds or gastric perforation. 12. Patients with a history of stroke or heart attack. 13. Patients currently receiving an aspirin or NSAID regimen (exception: low dose (81 mg) aspirin. See section 6.5) Patients with any bleeding disorders. 14. Patients with severe renal failure. Patients with moderate renal failure may participate in the study at a modified dose. See Section 9.6. 15. Patients undergoing daily treatment with systemic glucocorticoids before surgery. 16. Patients using angiotensin-converting enzyme (ACE) inhibitors, who may be at increased risk of developing angioedema with pregabalin. 17. 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. 18. Patients who experienced a loss of consciousness consistent with a clinical diagnosis of a closed head injury, or concern of a cerebrovascular bleed secondary to traumatic brain injury. 19. Patients with a GCS <15 20. Patient speaks neither English nor Spanish. 21. Patients who are pregnant or lactating at time of screening
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: July 2013
Completed Date: December 2018
Phase: Phase 3
Primary Outcome: Opioid Utilization
Secondary Outcome: Post Surgical Pain Intensity
Study sponsors, principal investigator, and references
Principal Investigator: Renan Castillo, PhD
Lead Sponsor: Major Extremity Trauma Research Consortium