Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Brooke Army Medical Center
University of Pennsylvania
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00431847
First received: February 2, 2007
Last updated: December 20, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Anxiety Disorders
Complex Regional Pain Syndrome Type II
Depressive Disorders
Post-Traumatic Stress Disorder
Substance Abuse
Procedure: Regional Anesthesia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 670
Study Start Date: October 2007
Estimated Study Completion Date: March 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1
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.
Group 2
Soldiers with one or more severely injured, mangled or amputated limbs from the Iraq/Afghanistan war receiving standard treatment for pain control.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Soldiers with one or more severely injured, mangled or amputated limbs from Iraq/Afghanistan war.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00431847

Locations
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
Sponsors and Collaborators
Walter Reed National Military Medical Center
Brooke Army Medical Center
University of Pennsylvania
Investigators
Principal Investigator: Rollin McCulloch Gallagher, MD MPH Pain Management Service
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00431847     History of Changes
Obsolete Identifiers: NCT01710475
Other Study ID Numbers: D4506-I
Study First Received: February 2, 2007
Last Updated: December 20, 2013
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Anesthesia, Regional
Causalgia
Trauma
Complex Regional Pain Syndrome Type II
Neuropathic Pain
PTSD
Combat Stress Disorders
Afghan War, 2001-
Iraq War, 2003-

Additional relevant MeSH terms:
Anxiety Disorders
Causalgia
Depressive Disorder
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Complex Regional Pain Syndromes
Substance-Related Disorders
Mental Disorders
Autonomic Nervous System Diseases
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Neuralgia
Mood Disorders
Behavioral Symptoms
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 22, 2014