Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)

Completed · Phase 3 · Has a placebo group

Conditions studied: Orthopaedic Fractures

In brief

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.

Key facts

Study ID

NCT01789216

Run by

Major Extremity Trauma Research Consortium

People needed

450

Starts

2013-07-01

Expected to finish

2018-12-31

Last updated by the study team

2021-02-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Miami Ryder Trauma Center — Miami, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• Eskenazi Health — Indianapolis, Indiana, United States
• University of Iowa Hospitals & Clinics — Iowa City, Iowa, United States
• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Maryland, R Adams Cowley Shock Trauma Center — Baltimore, Maryland, United States
• Boston Medical Center — Boston, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Penn State University M.S. Hershey Medical Center — Hershey, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• UT Health: The University of Texas Health Science Center at Houston Medical School — Houston, Texas, United States
• Naval Medical Center Portsmouth — Portsmouth, Virginia, United States

Full record on ClinicalTrials.gov

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