Clinical trial NCT00431847: Regional Anesthesia Military Battlefield Pain Outcomes Study
Official title: Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anxiety Disorders
Complex Regional Pain Syndrome Type II
Depressive Disorders
Post-Traumatic Stress Disorder
Substance Abuse
Keywords: Anesthesia, Regional
Causalgia
Trauma
Complex Regional Pain Syndrome Type II
Neuropathic Pain
PTSD
Combat Stress Disorders
Afghan War, 2001-
Iraq War, 2003-
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Walter Reed National Military Medical Center
name: Brooke Army Medical Center
name: University of Pennsylvania
First posted: 2007-02-06
Enrollment: 386
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Military service members with one or more severely injured, mangled or amputated limbs from Iraq/Afghanistan war.

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 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 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, 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 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

Primary outcomes:
measure: Neuropathic Pain Scale - Pain Intensity
timeFrame: 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
measure: Neuropathic Pain Scale - Overall Pain Quality
timeFrame: 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
measure: Neuropathic Pain Scale - Total Score
timeFrame: 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
measure: Brief Pain Inventory - Worst Pain
timeFrame: 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
measure: Brief Pain Inventory - Average Pain
timeFrame: 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
measure: Brief Pain Inventory - Pain Interference
timeFrame: 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
measure: Brief Pain Inventory - Treatment Relief
timeFrame: 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
measure: SF-36 Physical Component Summary
timeFrame: 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
measure: SF-36 Mental Component Summary
timeFrame: 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
measure: Post Traumatic Stress Disorder (PTSD) Total Severity
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS):Life Control
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms
timeFrame: 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
measure: Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Philadelphia
country: United States
facility: Pain Management Service
state: Pennsylvania
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center & US Army Institute of Surgical Research
state: Texas
Study officials:
affiliation: Pain Management Service
name: Rollin M Gallagher, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallagher RM, Polomano RC, Giordano NA, Farrar JT, Guo W, Taylor L, Oslin D, Goff BJ, Buckenmaier CC. Prospective cohort study examining the use of regional anesthesia for early pain management after combat-related extremity injury. Reg Anesth Pain Med. 2019 Sep 27:rapm-2019-100773. doi: 10.1136/rapm-2019-100773. Online ahead of print.