Regional Anesthesia Military Battlefield Pain Outcomes Study

Completed

Conditions: Complex Regional Pain Syndrome Type II
Depressive Disorders
Anxiety Disorders
Post-Traumatic Stress Disorder
Substance Abuse

Interventions: Procedure: Regional Anesthesia
Procedure: Standard Pain Management Protocol

Registration Number: NCT00431847

Lead Sponsor: VA Office of Research and Development

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 386

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

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 1	Regional Anesthesia	Soldiers with one or more severely injured, mangled or amputated limbs from the Iraq/Afghanistan war aggressively treated with regional anesthesia for pain control.
Group 2	Standard Pain Management Protocol	Soldiers with one or more severely injured, mangled or amputated limbs from the Iraq/Afghanistan war receiving standard treatment for pain control.

Primary Outcome Measures

Name	Time	Method
Neuropathic Pain Scale - Pain Intensity	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 - Total Score	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. It has a scale of 0 - 10, where "0" is no pain and "10" is the most intense sensation imaginable. The NPS total score is an average of all ten items.
Neuropathic Pain Scale - Overall Pain Quality	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.
Brief Pain Inventory - Worst Pain	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 Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Worst Pain asks the respondent to rate worst pain in the past week from the combat limb injury on a scale of 0 to 10, where "0" is no pain, and "10" is pain as bad as you can imagine.
Brief Pain Inventory - Average Pain	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 Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. BPI Item - Average Pain asks the respondent to rate combat limb injury pain on average (no time frame given) on a scale of 0 to 10, where "0" is no pain, and "10" is pain as bad as you can imagine.
Brief Pain Inventory - Pain Interference	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 Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is scored as the mean of the seven interference items, each ranging 0 to 10, where "0" is pain from combat limb injury does not interfere and "10" is pain from combat limb injury completely interferes with this aspect of daily life.
Brief Pain Inventory - Treatment Relief	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 Brief Pain Inventory - Short form (BPI) is a 17-item self-report questionnaire designed to assess the severity of pain and the degree to which pain interferes with common dimensions of feeling and function. The BPI measures in the last 24 hours, how much relief pain treatments or medications provided on a scale of 0%, meaning no relief, to 100%, indicating complete relief.
SF-36 Physical Component Summary	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 Physical component score (PCS) is an aggregate of the eight subscale scores measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is calculated for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the PCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the PCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996
Post Traumatic Stress Disorder (PTSD) Total Severity	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	Post-Traumatic Stress Disorder Checklist (PCL): The PCL is a 17-item PTSD assessment instrument that asks respondents to rate the extent to which they have experienced each of the 17 diagnostic symptoms for PTSD outlined in the Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV). Scores are computed by adding the 17 items scored 1 to 5. Scores range from 17 to 85. Higher scores indicate higher severity of symptoms.
Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the health care satisfaction scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.
Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
SF-36 Mental Component Summary	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 Mental component score (MCS) is an aggregate of the eight subscale scores that account for measuring physical components with each subscale ranging from worst possible health, 0, to 100, the highest possible score and therefore the optimal health state. After the eight scale scores are calculated, a z-score is determined for each by subtracting the scale mean of a sample of the U.S. general population from an individual's scale score and then dividing by the standard deviation from the U.S. general population. Each of the eight z-scores is then multiplied by the corresponding factor scoring coefficient for the scale. The products of the z-scores and factor scoring coefficients for the MCS are then summed together. Each resulting sum is multiplied by 10 and added to 50 to linearly transform the MCS to the T-score metric, which has a mean of 50 and a standard deviation of 10 for the U.S. general population (Taft et al., 2001) doi:10.1023/A:1012552211996
Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. For the satisfaction with outcomes scale of the TOPS, scoring ranges from 100, the best possible score where satisfaction is optimal, to 0, least satisfied.
Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Treatment Outcomes in Pain Survey (TOPS):Life Control	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.
Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms	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	Treatment Outcomes in Pain Survey (TOPS): The 112-item TOPS explicitly acknowledges and measures contextual factors that are important in pain treatment including the dimensions of pain symptoms, fear avoidance, patient satisfaction with outcomes, and health care satisfaction. TOPS scoring ranges from 100, the worst possible score where pain impacts all components of the health domain, to 0, the best possible response where pain does not interfere with any component in the domain.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (3): Walter Reed National Military Medical Center
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Bethesda, Maryland, United States
Brooke Army Medical Center & US Army Institute of Surgical Research
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Fort Sam Houston, Texas, United States
Pain Management Service
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Philadelphia, Pennsylvania, United States