Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)

Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Substance Abuse; Post-Traumatic Stress Disorder; Depressive Disorders; Complex Regional Pain Syndrome Type II
• Intervention / Treatment: Procedure: Regional Anesthesia; Procedure: Standard Pain Management Protocol

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.

• Study Type: Observational
• Enrollment (Actual): 386

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20889
      • Walter Reed National Military Medical Center
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Pain Management Service
  • Texas
    • Fort Sam Houston, Texas, United States, 78234
      • Brooke Army Medical Center & US Army Institute of Surgical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Procedure: Standard Pain Management Protocol; Intermittent dosing of analgesics and anxiolytics instituted prior to continuous intravenously dosing which was individually titrated to patient care goals.; Other Names: No RA Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic Pain Scale - Pain Intensity	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.	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
Neuropathic Pain Scale - Overall Pain Quality	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.	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
Neuropathic Pain Scale - Total Score	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.	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
Brief Pain Inventory - Worst Pain	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.	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
Brief Pain Inventory - Average Pain	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.	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
Brief Pain Inventory - Pain Interference	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.	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
Brief Pain Inventory - Treatment Relief	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.	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
SF-36 Physical Component Summary	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	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
SF-36 Mental Component Summary	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	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 (PTSD) Total Severity	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.	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): Fear Avoidance	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.	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): Health Care Satisfaction	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.	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):Life Control	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.	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): Observed Family Social Disability	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.	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): Patient Satisfaction With Outcomes	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.	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): Pain Symptoms	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.	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): Solicitous Responses	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.	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

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Collaborators: University of Pennsylvania; Walter Reed National Military Medical Center; Brooke Army Medical Center
• Investigators: Principal Investigator: Rollin M Gallagher, MD MPH, Pain Management Service

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: October 1, 2007
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 2, 2007
• First Submitted That Met QC Criteria: February 5, 2007
• First Posted (Estimate): February 6, 2007

Study Record Updates

• Last Update Posted (Actual): May 15, 2017
• Last Update Submitted That Met QC Criteria: May 4, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Keywords: PTSD; Trauma; Neuropathic Pain; Causalgia; Anesthesia, Regional; Complex Regional Pain Syndrome Type II; Combat Stress Disorders; Afghan War, 2001-; Iraq War, 2003-
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Nervous System Diseases; Mood Disorders; Neuromuscular Diseases; Peripheral Nervous System Diseases; Neuralgia; Trauma and Stressor Related Disorders; Autonomic Nervous System Diseases; Substance-Related Disorders; Depressive Disorder; Disease; Anxiety Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Complex Regional Pain Syndromes; Reflex Sympathetic Dystrophy; Causalgia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: D4506-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO