Improving Pain Management and Long-Term Outcomes Following High-Energy Orthopaedic Trauma (Pain Study).
Poor pain control after orthopaedic trauma is a predictor of physical disability and numerous negative long-term outcomes. Despite increased awareness of the negative consequences of poorly controlled pain, analgesic therapy among hospitalized patients after orthopaedic trauma remains inconsistent and often inadequate. The Pain study is a 3 armed, prospective, double-blind, multicenter randomized trial designed to evaluate the effect of standard pain management versus standard pain management plus perioperative nonsteroidal anti-inflammatory drugs or pregabalin in patients of ages 18-85 with extremity fractures. The primary outcomes are chronic pain, opioid utilization during the 48 hours after definitive fixation and surgery for nonunion in the year after fixation. Secondary outcomes include preoperative and postoperative pain intensity, adverse events and complications, physical function, depression, and post-traumatic stress disorder. One year treatment costs are also compared between the groups.
*Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; †Department of Anesthesiology and Critical Care Medicine, Johns Hopkins School of Medicine; ‡Department of Orthopaedics, The MetroHealth Medical Center, Case Western Reserve University, Cleveland, OH; §Department of Orthopaedic Surgery, Boston University Medical Center, Boston, MA; ‖Department of Orthopaedic Surgery, Louisiana State University Health Shreveport, Shreveport, LA; ¶Department of Pain Management, Brooke Army Medical Center, San Antonio, TX; **Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; and ††R Adams Cowley Shock Trauma Center, Department of Orthopaedics, University of Maryland School of Medicine, Baltimore, MD.
Renan C
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Castillo
Srinivasa N
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Raja
Katherine P
KP
Frey
Heather A
HA
Vallier
Paul
P
Tornetta
Todd
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Jaeblon
Brandon J
BJ
Goff
Allan
A
Gottschalk
Daniel O
DO
Scharfstein
Robert V
RV
OʼToole
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000701:Analgesics, Opioid / Q000008:administration & dosage*; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D059350:Chronic Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination / Q000379:methods; D005260:Female; D005592:Fracture Fixation / Q000009:adverse effects*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D059408:Pain Management / Q000379:methods*; D010147:Pain Measurement / Q000187:drug effects; D010149:Postoperative Pain / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D011446:Prospective Studies; D058996:Quality Improvement; D016896:Treatment Outcome; D014481:United States; D055815:Young Adult
D000701:Analgesics, Opioid; D000894:Anti-Inflammatory Agents, Non-Steroidal