Regional Anesthesia Military Battlefield Pain Outcomes Study
This trial is active, not recruiting.
|Conditions||anxiety disorders, complex regional pain syndrome type ii, depressive disorders, post-traumatic stress disorder, substance abuse|
|Sponsor||Department of Veterans Affairs|
|Collaborator||Walter Reed National Military Medical Center|
|Start date||October 2007|
|End date||September 2013|
|Trial size||670 participants|
|Trial identifier||NCT00431847, D4506-I, NCT01710475|
The purpose of this study is to examine the short and long-term benefits of implementing early regional anesthesia techniques for pain control after a major traumatic injury to one or more extremities during combat in the Iraqi/Afghanistan war, including the effects on acute and chronic pain, quality of life, and mental health.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Fort Sam Houston, TX||Brooke Army Medical Center & US Army Institute of Surgical Research||no longer recruiting|
|Philadelphia, PA||Pain Management Service||no longer recruiting|
|Bethesda, MD||Walter Reed National Military Medical Center||no longer recruiting|
Total Outcomes of Pain Survey (TOPS), a pain-specific health-related quality of life instrument.
time frame: Two years from start of injury rehabilitation
Male or female participants of any age.
- Major injury in one or more extremities requiring hospitalization and inpatient rehabilitation.
- Major head trauma
- Cognitive deficits
- Inability to concentrate
- Poor judgment and impulse control
- Substantial hearing loss
- Bilateral upper extremity amputation with no alternate means to complete the survey forms
|Official title||Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes|
|Principal investigator||Rollin McCulloch Gallagher, MD MPH|
|Description||BACKGROUND: Adequate pain management for combat casualties balances the need for emergent, life-saving care with the urgency to remove soldiers from harm's way. Control of pain in traumatic battlefield situations may be impossible until safe evacuation to a surgical facility is achieved and a wounded soldier can receive general anesthesia. Recent evidence suggests that neural plasticity in the central nervous system coupled with hyperstimulation of central neuronal pathways lead to neuropathological remodeling. This neural rewiring may result in chronic pain for patients who have experienced severe, unrelieved acute pain. In addition, the stress of combat along with the suffering of prolonged uncontrolled pain may contribute to psychological disorders, such as post-traumatic stress disorder, depression, and substance abuse. OBJECTIVE: The purpose of this study is to evaluate the effect of early and aggressive advanced regional anesthesia on the chronic neuropathic pain, health related quality of life, and mental health of OEF/OIF veterans who have suffered a major limb injury in combat. An additional aim of this study is to quantify and characterize the short-term and long-term effects of traumatic combat limb injuries on post-injury acute pain, chronic pain, health related quality of life, functional status, social reintegration, psychological adjustment, and substance abuse behaviors in a population of injured military personnel. METHOD: This study employs a cohort repeated measures study design involving prospective data collection at scheduled intervals. Interviews with participants provide data on pain outcomes, psychiatric morbidities, and quality of life. Follow up evaluations conclude at the two year anniversary of the start of combat injury rehabilitation. Medical records information collected retrospectively from armed services treatment facilities provide data on the use of pain management therapies as well as individual responses to regional anesthesia. IMPLICATIONS FOR RESULTS: The findings of this study may impact the clinical field by providing information on the effectiveness and benefits of early advanced regional anesthesia for chronic pain control. This study may also provide data to determine whether regional anesthesia pain treatments prevent or reduce the development of psychological maladjustment disorders such as post-traumatic stress disorder, depression, and substance abuse in a population of military personnel with combat limb injuries.|
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