Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study) (PAIN)
Orthopaedic Fractures
About this trial
This is an interventional treatment trial for Orthopaedic Fractures focused on measuring Pilon fractures, Calcaneus fractures, Acute pain, Chronic pain, Isolated, unilateral, Grade I, Grade II, open, closed
Eligibility Criteria
Inclusion Criteria:
Patients with one of the following types of injuries:
- Unilateral, Grade I &II open or closed pilon (distal tibial plafond), calcaneus, talus fractures and Lisfranc dislocations requiring operative treatment with fixation; or
- Unilateral, open (type I, II, or IIIA) ankle fractures with associated dislocation on presentation (OTA 44B3 or 44C) requiring operative treatment with fixation; or
- Unilateral, open or closed distal and proximal humerus (OTA 11A-C and OTA 13 A-C); or
- Open femoral shaft fracture (OTA 32 A-C; Gustilo Type I-IIIC) or open or closed supracondylar femur fractures (OTA 33 A-C); or
- Open or closed tibial plateau or shaft fractures (OTA 42 A-C or 43 A-C)
- Any combination of the above injuries which are surgically treated as a whole
- 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.
- Patients 18-80 years old inclusive.
- Patients who are English or Spanish competent.
- Treating physicians agree that none of the study drugs are indicated for standard of care treatment for this patient.
- Patients able to be followed at the METRC facility for at least 12 months following injury.
Exclusion Criteria:
- Patients unable to provide informed consent.
- Patients with chronic pain being presently treated with opioid or gabapentinoid prescription or any other alternative therapy.
- Patients who are current IVDA
- Patients with bilateral or ipsilateral injuries requiring surgery
- Patients with other orthopedic or non-orthopedic injuries requiring operative intervention
- Patients with severe osteopenia.
- Patients who are skeletally immature (defined as less than 18 years of age or no radiographic evidence of epiphyseal closure).
- Patients who are expected to have a post-surgical stay less than 24 hours.
- Patients with a history of allergy to any drugs in the study.
- Patients unable to swallow oral medications or without adequately functioning GI tract.
- Patients with a history of gastrointestinal bleeds or gastric perforation.
- Patients with a history of stroke or heart attack.
- Patients currently receiving an aspirin or NSAID regimen (exception: low dose (81 mg) aspirin. See section 6.5) Patients with any bleeding disorders.
- Patients with severe renal failure. Patients with moderate renal failure may participate in the study at a modified dose. See Section 9.6.
- Patients undergoing daily treatment with systemic glucocorticoids before surgery.
- Patients using angiotensin-converting enzyme (ACE) inhibitors, who may be at increased risk of developing angioedema with pregabalin.
- 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 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.
- Patients with a GCS <15
- Patient speaks neither English nor Spanish.
- Patients who are pregnant or lactating at time of screening
Sites / Locations
- University of Miami Ryder Trauma Center
- St. Mary's Medical Center
- Eskenazi Health
- University of Iowa Hospitals & Clinics
- Louisiana State University Health Sciences Center
- Johns Hopkins University
- University of Maryland, R Adams Cowley Shock Trauma Center
- Boston Medical Center
- Hennepin County Medical Center
- Carolinas Medical Center
- MetroHealth Medical Center
- Penn State University M.S. Hershey Medical Center
- University of Pittsburgh
- Vanderbilt University Medical Center
- University of Texas Southwestern Medical Center
- UT Health: The University of Texas Health Science Center at Houston Medical School
- Naval Medical Center Portsmouth
Arms of the Study
Arm 1
Arm 2
Arm 3
Placebo Comparator
Active Comparator
Active Comparator
Placebo
NSAID
Gabapentinoid
Standard pain management + perioperative intravenous placebo & oral placebo. Control group will receive an oral dose of placebo up to two hours prior to surgery and twice daily for up to 48 hours following any surgery, in addition to an intravenous dose of placebo up to two hours prior to surgery and every 6 hours for up to 48 hours following surgery. All study medications will be in addition to standard of care pain medication. *Previous preoperative protocol was removed due to difficulty of medication adherence and limited importance of preoperative regimen to the intervention overall.
Standard pain management + perioperative intravenous ketorolac & oral placebo. The NSAID group will receive 30 mg of intravenous (IV) ketorolac (Ketorolac 30 mg/ml dose vial, NDC 00409-3795-01; manufacturer: Hospira) administered up to two hours prior to the procedure and every 6 hours for up to 48 hours following the procedure. In addition, as part of the perioperative protocol, patients will receive an oral dose of placebo up to two hours prior to the procedure and every 12 hours for up to 48 hours following the procedure. *Previous preoperative protocol was removed due to difficulty of medication adherence and limited importance of preoperative regimen to the intervention overall.
Standard pain management + perioperative intravenous placebo & oral pregabalin. The Pregabalin group will receive an oral bolus dose of 300 mg of pregabalin up to two hours prior to the procedure and a 75 mg dose every 12 hours for up to 48 hours following the procedure. In addition, as part of the perioperative protocol, patients will receive an IV dose of placebo up to two hours prior to the procedure and every 6 hours for up to 48 hours following the procedure. *Previous preoperative protocol was removed due to difficulty of medication adherence and limited importance of preoperative regimen to the intervention overall.