Regional Anesthesia Military Battlefield Pain Outcomes Study

NCT00431847 | Completed Results

• 1 other identifier: D4506-I
• Study Type: observational
• Target: 386
• Locations: 1 country
• Sites: 3

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.

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-

Outcome Measures

Primary Outcomes (17)

• 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

Study Arms (2)

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

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

Interventions

Regional Anesthesia PROCEDURE

Subject received regional anesthesia to affected limb(s) within 72 hours of traumatic event.

Group 1

Standard Pain Management Protocol PROCEDURE

Intermittent dosing of analgesics and anxiolytics instituted prior to continuous intravenously dosing which was individually titrated to patient care goals.

Also known as: No RA Group

Group 2

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Major injury in one or more extremities requiring hospitalization and inpatient rehabilitation.

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Walter Reed National Military Medical Center: collaborator
• Brooke Army Medical Center: collaborator
• University of Pennsylvania: collaborator

Study Sites (3)

Walter Reed National Military Medical Center

Bethesda, Maryland, 20889, United States

Location

Pain Management Service

Philadelphia, Pennsylvania, 19104, United States

Location

Brooke Army Medical Center & US Army Institute of Surgical Research

Fort Sam Houston, Texas, 78234, United States

Location

Related Publications (1)

• 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.

  PMID: 31563880 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Causalgia; Depressive Disorder; Stress Disorders, Post-Traumatic; Substance-Related Disorders; Wounds and Injuries; Neuralgia; Combat Disorders

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Mental Disorders; Complex Regional Pain Syndromes; Autonomic Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Mood Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Chemically-Induced Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Rollin M Gallagher, MD, MPH
• Organization: Philadelphia Veterans Affairs Medical Center

Rollin.Gallagher@va.gov

(215) 823-5800

Study Officials

• Rollin M Gallagher, MD MPH

  Pain Management Service

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2007
• First Posted: February 6, 2007
• Study Start: October 1, 2007
• Primary Completion: September 1, 2013
• Study Completion: November 1, 2014
• Last Updated: May 15, 2017
• Results First Posted: May 15, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)