Clinical Trial: Regional Anesthesia Military Battlefield Pain Outcomes Study

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes

Brief 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.

Detailed Summary:

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 Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (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,
Sponsor: VA Office of Research and Development

Current Primary Outcome:

  • Neuropathic Pain Scale - Pain Intensity [ Time Frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months ]
    The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. Item numbers ask respondents to describe the intensity of their combat limb pain on a scale of 0 - 10, where "0" is no pain and "10" is the most intense pain imaginable.
  • Neuropathic Pain Scale - Overall Pain Quality [ Time Frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months ]
    The Neuropathic Pain Scale (NPS) is a 10-item self-report questionnaire designed to assess the distinct pain qualities associated with neuropathic pain, pain initiated or caused by a dysfunction of the nervous system. The NPS Overall Pain Quality composite score is a measure of six distinct pain qualities of respondents' combat limb pain on a scale of 0 - 10, where "0" is no pain and "10" is the most intense sensation imaginable. The six pain qualities included in the composite score is sharp, hot, dull, cold, itchy, and sensitive to touch.
  • Neuropathic Pain Scale - Total Score [ Time Frame: Means of the individuals aggregated to the cohort level from start of rehabilitation for combat injury, month 0, to end of study follow up, at 30 months ]
    The Neuropathic Pain Scale (NPS) is a 10-ite

    Original Primary Outcome:

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: VA Office of Research and Development

    Dates:
    Date Received: February 2, 2007
    Date Started: October 2007
    Date Completion:
    Last Updated: May 4, 2017
    Last Verified: May 2017