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 range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.
. 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.