Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain St… (NCT01789216) | Clinical Trial Compass
CompletedPhase 3
Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)
United States450 participantsStarted 2013-07
Plain-language summary
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 can participate
Age range18 Years – 80 Years
SexALL
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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.
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.