This trial is active, not recruiting.

Conditions anxiety disorders, complex regional pain syndrome type ii, depressive disorders, post-traumatic stress disorder, substance abuse
Treatment regional anesthesia
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

Study Design

Observational model cohort
Time perspective prospective
Soldiers with one or more severely injured, mangled or amputated limbs from the Iraq/Afghanistan war aggressively treated with regional anesthesia for pain control.
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.

Primary 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

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Major injury in one or more extremities requiring hospitalization and inpatient rehabilitation. Exclusion Criteria: - 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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Department of Veterans Affairs.