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

CompletedPhase 3NCT01789216
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
Improving Pain Management and Long Term Outcomes Following High Energy Orthopedic Trauma (Pain Study)
Conditions
  • Orthopaedic Fractures
Interventions
Sponsor
Major Extremity Trauma Research Consortium
Start date
2013-07
Primary completion
2018-12-31
Sex
All
Age range
from 18 Years to 80 Years
Results posted
No results posted in this snapshot
Countries
United States
Total sites listed
17

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: 1. Patients with one of the following types of injuries: 1. Unilateral, Grade I \&II open or closed pilon (distal tibial plafond), calcaneus, talus fractures and Lisfranc dislocations requiring operative treatment with fixation; 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…

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01789216