Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)
Recruitment status was Active, not recruiting
Complex Regional Pain Syndrome Type II
Post-Traumatic Stress Disorder
Procedure: Regional Anesthesia
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes|
- Total Outcomes of Pain Survey (TOPS), a pain-specific health-related quality of life instrument. [ Time Frame: Two years from start of injury rehabilitation ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Estimated Study Completion Date:||November 2014|
|Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Soldiers with one or more severely injured, mangled or amputated limbs from the Iraq/Afghanistan war aggressively treated with regional anesthesia for pain control.
Procedure: Regional Anesthesia
Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.
Soldiers with one or more severely injured, mangled or amputated limbs from the Iraq/Afghanistan war receiving standard treatment for pain control.
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.
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431847
|United States, Maryland|
|Walter Reed National Military Medical Center|
|Bethesda, Maryland, United States, 20889|
|United States, Pennsylvania|
|Pain Management Service|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Texas|
|Brooke Army Medical Center & US Army Institute of Surgical Research|
|Fort Sam Houston, Texas, United States, 78234|
|Principal Investigator:||Rollin McCulloch Gallagher, MD MPH||Pain Management Service|