Regional Anesthesia Military Battlefield Pain Outcomes Study

Anxiety Disorders Clinical Trial

— RAMBPOS  

Official title:

Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00431847
• Other study ID #: D4506-I
• Status: Active, not recruiting
• Phase: N/A
• First received: February 2, 2007
• Last updated: October 24, 2014
• Start date: October 2007
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT01710475

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 670
• Est. completion date: November 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anxiety Disorders
• Causalgia
• Complex Regional Pain Syndrome Type II
• Complex Regional Pain Syndromes
• Depression
• Depressive Disorder
• Depressive Disorders
• Disease
• Post-Traumatic Stress Disorder
• Reflex Sympathetic Dystrophy
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Substance Abuse

Intervention

Procedure:
• Regional Anesthesia
Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.

Locations

Country	Name	City	State
United States	Walter Reed National Military Medical Center	Bethesda	Maryland
United States	Brooke Army Medical Center & US Army Institute of Surgical Research	Fort Sam Houston	Texas
United States	Pain Management Service	Philadelphia	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
VA Office of Research and Development	Brooke Army Medical Center, University of Pennsylvania, Walter Reed National Military Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Outcomes of Pain Survey (TOPS), a pain-specific health-related quality of life instrument.		Two years from start of injury rehabilitation	No