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RAMBPOS: Regional Anesthesia Military Battlefield Pain Outcomes Study

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT00431847
Collaborator
Walter Reed National Military Medical Center (U.S. Fed), Brooke Army Medical Center (U.S. Fed), University of Pennsylvania (Other)
386
Enrollment
3
Locations
85
Duration (Months)
128.7
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
386 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Regional Anesthesia in Combat Trauma Improves Pain Disability Outcomes
Study Start Date :
Oct 1, 2007
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Nov 1, 2014

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. 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.

    7. 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.

    8. 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

    9. 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

    10. 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.

    11. 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.

    12. 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.

    13. 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.

    14. 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.

    15. 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.

    16. 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.

    17. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Walter Reed National Military Medical Center Bethesda Maryland United States 20889
    2 Pain Management Service Philadelphia Pennsylvania United States 19104
    3 Brooke Army Medical Center & US Army Institute of Surgical Research Fort Sam Houston Texas United States 78234

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Rollin M Gallagher, MD MPH, Pain Management Service

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT00431847
    Other Study ID Numbers:
    • D4506-I
    • NCT01710475
    First Posted:
    Feb 6, 2007
    Last Update Posted:
    May 15, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by VA Office of Research and Development
    Anesthesia, Regional
    Causalgia
    Trauma
    Complex Regional Pain Syndrome Type II
    Neuropathic Pain
    PTSD
    Combat Stress Disorders
    Afghan War, 2001-
    Iraq War, 2003-
    Additional relevant MeSH terms:
    Complex Regional Pain Syndromes
    Reflex Sympathetic Dystrophy
    Causalgia
    Disease
    Substance-Related Disorders
    Depressive Disorder
    Stress Disorders, Traumatic
    Anxiety Disorders
    Stress Disorders, Post-Traumatic
    Anesthetics

    Study Results

    Participant Flow

    Recruitment Details Six hundred eighty-seven (687) combat-injured military service members hospitalized with at least one major limb injury were assessed for eligibility as an inpatient at one of two military treatment facilities. Three hundred one (301) of these patients did not meet criteria for study enrollment.
    Pre-assignment Detail Three hundred eighty-six (386) participants provided study data. Twenty-Eight (28) of these participants were excluded from group observation due to completion of less than two study visits.
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA) Unknown Treatment Status
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia. No patient data on exposure to Regional Anesthesia
    Period Title: Overall Study
    STARTED 132 45 24 184 1
    COMPLETED 126 42 20 170 0
    NOT COMPLETED 6 3 4 14 1

    Baseline Characteristics

    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA) Total
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia. Total of all reporting groups
    Overall Participants 126 42 20 170 358
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    28.20
    (6.30)
    26.68
    (4.80)
    29.08
    (8.97)
    28.15
    (7.87)
    28.04
    (7.10)
    Sex: Female, Male (Count of Participants)
    Female
    0
    0%
    1
    2.4%
    0
    0%
    2
    1.2%
    3
    0.8%
    Male
    126
    100%
    41
    97.6%
    20
    100%
    168
    98.8%
    355
    99.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    14
    11.1%
    8
    19%
    4
    20%
    19
    11.2%
    45
    12.6%
    Not Hispanic or Latino
    112
    88.9%
    34
    81%
    16
    80%
    151
    88.8%
    313
    87.4%
    Unknown or Not Reported
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    2
    1.6%
    1
    2.4%
    0
    0%
    6
    3.5%
    9
    2.5%
    Asian
    5
    4%
    3
    7.1%
    0
    0%
    6
    3.5%
    14
    3.9%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    5
    4%
    0
    0%
    2
    10%
    12
    7.1%
    19
    5.3%
    White
    101
    80.2%
    31
    73.8%
    17
    85%
    129
    75.9%
    278
    77.7%
    More than one race
    12
    9.5%
    6
    14.3%
    1
    5%
    17
    10%
    36
    10.1%
    Unknown or Not Reported
    1
    0.8%
    1
    2.4%
    0
    0%
    0
    0%
    2
    0.6%
    Education (participants) [Number]
    High School/GED
    47
    37.3%
    18
    42.9%
    8
    40%
    74
    43.5%
    147
    41.1%
    Some College
    47
    37.3%
    18
    42.9%
    9
    45%
    72
    42.4%
    146
    40.8%
    Bachelor's Degree or Higher
    32
    25.4%
    6
    14.3%
    3
    15%
    24
    14.1%
    65
    18.2%
    Marital Status (participants) [Number]
    Never Married
    51
    40.5%
    19
    45.2%
    7
    35%
    89
    52.4%
    166
    46.4%
    Married or Living w/Partner
    70
    55.6%
    22
    52.4%
    13
    65%
    67
    39.4%
    172
    48%
    Separated/Divorced
    5
    4%
    1
    2.4%
    0
    0%
    14
    8.2%
    20
    5.6%
    Number of Deployments, Continuous (deployments) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [deployments]
    2.13
    (1.27)
    1.80
    (0.90)
    2.40
    (2.54)
    1.85
    (1.05)
    1.97
    (1.25)
    Injury Severity Score (ISS) (units on a scale) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [units on a scale]
    17.31
    (8.56)
    19.74
    (11.88)
    24.65
    (12.59)
    18.07
    (11.57)
    18.37
    (10.79)
    Length of Initial Hospital Stay (months) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [months]
    41.14
    (30.54)
    47.45
    (33.74)
    59.90
    (47.64)
    27.95
    (30.72)
    36.69
    (33.35)

    Outcome Measures

    1. Primary Outcome
    Title Neuropathic Pain Scale - Pain Intensity
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the Neuropathic Pain Scale]
    3
    (0.16)
    3.44
    (0.3)
    3.92
    (0.45)
    3.04
    (0.15)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.03230
    Confidence Interval (2-Sided) 95%
    -0.0448 to -0.02013
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.006190
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4492
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi Squared
    Estimated Value 2.65
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.640
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.1080
    Confidence Interval (2-Sided) 95%
    -0.5621 to 0.3461
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2308
    Estimation Comments Estimated intercept group difference
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3286
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.3299
    Confidence Interval (2-Sided) 95%
    -0.3334 to 0.9932
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3372
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0694
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.8591
    Confidence Interval (2-Sided) 95%
    -0.06841 to 1.7866
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.4716
    Estimation Comments
    2. Primary Outcome
    Title Neuropathic Pain Scale - Overall Pain Quality
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the Neuropathic Pain Scale]
    1.90
    (0.11)
    2.04
    (0.20)
    2.13
    (0.27)
    1.82
    (0.10)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.02332
    Confidence Interval (2-Sided) 95%
    -0.03076 to -0.01589
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.003777
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4772
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 2.49
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6077
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.07724
    Confidence Interval (2-Sided) 95%
    -0.2184 to 0.3729
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1503
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3616
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.2004
    Confidence Interval (2-Sided) 95%
    -0.2311 to 0.6319
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2194
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3155
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.3082
    Confidence Interval (2-Sided) 95%
    -0.2948 to 0.9112
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3066
    Estimation Comments
    3. Primary Outcome
    Title Neuropathic Pain Scale - Total Score
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the Neuropathic Pain Scale]
    2.35
    (0.12)
    2.60
    (0.22)
    2.80
    (0.31)
    2.29
    (0.11)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.02746
    Confidence Interval (2-Sided) 95%
    -0.03573 to -0.01919
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.004202
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3345
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 3.40
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8223
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.03860
    Confidence Interval (2-Sided) 95%
    -0.2993 to 0.3765
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1718
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2448
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.2919
    Confidence Interval (2-Sided) 95%
    -0.2009 to 0.7848
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2506
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2014
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.4482
    Confidence Interval (2-Sided) 95%
    -0.2405 to 1.1369
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3502
    Estimation Comments
    4. Primary Outcome
    Title Brief Pain Inventory - Worst Pain
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the Brief Pain Inventory Scale]
    4.54
    (0.18)
    4.95
    (0.36)
    5.83
    (0.44)
    4.62
    (0.19)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.04030
    Confidence Interval (2-Sided) 95%
    -0.5446 to -0.02613
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.007196
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3631
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 3.19
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7148
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.1004
    Confidence Interval (2-Sided) 95%
    -0.6404 to 0.4396
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2746
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3741
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.3568
    Confidence Interval (2-Sided) 95%
    -0.4318 to 1.1453
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.4009
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0213
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.2969
    Confidence Interval (2-Sided) 95%
    0.1938 to 2.4000
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.5609
    Estimation Comments
    5. Primary Outcome
    Title Brief Pain Inventory - Average Pain
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the Brief Pain Inventory Scale]
    2.18
    (0.13)
    2.45
    (0.23)
    3.21
    (0.42)
    2.45
    (0.13)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.02776
    Confidence Interval (2-Sided) 95%
    -0.03702 to -0.01850
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.004706
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2752
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 3.88
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1094
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.3079
    Confidence Interval (2-Sided) 95%
    -0.6851 to 0.06941
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1918
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8786
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.0428
    Confidence Interval (2-Sided) 95%
    -0.5079 to 0.5935
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2800
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0847
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.6759
    Confidence Interval (2-Sided) 95%
    -0.09297 to 1.4448
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3910
    Estimation Comments
    6. Primary Outcome
    Title Brief Pain Inventory - Pain Interference
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the Brief Pain Inventory Scale]
    1.91
    (0.15)
    2.03
    (0.25)
    2.57
    (0.46)
    1.88
    (0.14)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.03645
    Confidence Interval (2-Sided) 95%
    -0.04808 to -0.02481
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.005913
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3677
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 3.16
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7926
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.05816
    Confidence Interval (2-Sided) 95%
    -0.4929 to 0.3766
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.2210
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5953
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.1708
    Confidence Interval (2-Sided) 95%
    -0.4610 to 0.8026
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.3212
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1261
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.6873
    Confidence Interval (2-Sided) 95%
    -0.1943 to 1.5689
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.4482
    Estimation Comments
    7. Primary Outcome
    Title Brief Pain Inventory - Treatment Relief
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [percentage of pain relief]
    67.53
    (2.39)
    66.80
    (3.04)
    58.58
    (4.88)
    66.77
    (1.86)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.4831
    Confidence Interval (2-Sided) 95%
    -0.7286 to -0.2377
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1243
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3617
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 3.20
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2532
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.1574
    Confidence Interval (2-Sided) 95%
    -2.2715 to 8.5863
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.7573
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7580
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.2227
    Confidence Interval (2-Sided) 95%
    -6.5833 to 9.0286
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.9633
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1837
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -7.1649
    Confidence Interval (2-Sided) 95%
    -17.7484 to 3.4187
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.3759
    Estimation Comments
    8. Primary Outcome
    Title SF-36 Physical Component Summary
    Description 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
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [t-score]
    40.30
    (0.96)
    37.00
    (1.72)
    31.51
    (2.05)
    41.94
    (0.92)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value 0.4741
    Confidence Interval (2-Sided) 95%
    0.3971 to 0.5511
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.03909
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6075
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 1.83
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4558
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.9534
    Confidence Interval (2-Sided) 95%
    -3.4675 to 1.5607
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.2763
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0914
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -3.3505
    Confidence Interval (2-Sided) 95%
    -7.2442 to 0.5432
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.9770
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.007
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -8.3700
    Confidence Interval (2-Sided) 95%
    -14.4589 to -2.2810
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.0921
    Estimation Comments
    9. Primary Outcome
    Title SF-36 Mental Component Summary
    Description 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
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [t-score]
    52.47
    (1.11)
    52.12
    (1.84)
    49.90
    (2.94)
    51.30
    (0.82)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.2169
    Confidence Interval (2-Sided) 95%
    -0.2987 to -0.1352
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.04148
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0950
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 6.37
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5878
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.7246
    Confidence Interval (2-Sided) 95%
    -1.9056 to 3.3547
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.3351
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9053
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.2466
    Confidence Interval (2-Sided) 95%
    -4.3231 to 3.8299
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0697
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4682
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.3457
    Confidence Interval (2-Sided) 95%
    -8.7034 to 4.0120
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.2285
    Estimation Comments
    10. Primary Outcome
    Title Post Traumatic Stress Disorder (PTSD) Total Severity
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on the PCL scale]
    27.99
    (1.10)
    30.23
    (1.98)
    25.62
    (2.00)
    27.63
    (0.87)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1938
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value 0.04639
    Confidence Interval (2-Sided) 95%
    -0.02369 to 0.1165
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.03562
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4884
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 2.43
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6593
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 0.6174
    Confidence Interval (2-Sided) 95%
    -2.1348 to 3.3696
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.3991
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0889
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.4575
    Confidence Interval (2-Sided) 95%
    -0.5280 to 7.4431
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.0263
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8727
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.4499
    Confidence Interval (2-Sided) 95%
    -5.9692 to 5.0694
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.8061
    Estimation Comments
    11. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    41.85
    (2.07)
    43.57
    (3.65)
    51.27
    (6.29)
    40.62
    (1.91)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.5230
    Confidence Interval (2-Sided) 95%
    -0.6973 to -0.3486
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08855
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1800
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 4.89
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4151
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 2.3020
    Confidence Interval (2-Sided) 95%
    -3.2530 to 7.8570
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.8198
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3157
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 4.3376
    Confidence Interval (2-Sided) 95%
    -4.1592 to 12.8344
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.3140
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0911
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 11.8250
    Confidence Interval (2-Sided) 95%
    -1.9040 to 25.5541
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.9715
    Estimation Comments
    12. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    61.01
    (1.80)
    56.29
    (3.54)
    47.68
    (4.67)
    58.77
    (1.68)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0016
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.2888
    Confidence Interval (2-Sided) 95%
    -0.4675 to -0.1100
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.09078
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0966
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 6.33
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2195
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 2.9879
    Confidence Interval (2-Sided) 95%
    -1.7938 to 7.7697
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.4264
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5105
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -2.4636
    Confidence Interval (2-Sided) 95%
    -9.8289 to 4.9018
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.7381
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0903
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -10.3871
    Confidence Interval (2-Sided) 95%
    -22.4174 to 1.6433
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.1087
    Estimation Comments
    13. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS):Life Control
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    75.82
    (1.92)
    68.02
    (4.15)
    58.52
    (5.76)
    73.76
    (1.70)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6602
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.04113
    Confidence Interval (2-Sided) 95%
    -0.2252 to 0.1429
    Parameter Dispersion Type: Standard Error of the Mean
    Value: -0.04113
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6764
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 1.53
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3458
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 2.4902
    Confidence Interval (2-Sided) 95%
    -2.7036 to 7.6840
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.6357
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1969
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -5.2518
    Confidence Interval (2-Sided) 95%
    -13.2466 to 2.7430
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.0583
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0480
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -12.9796
    Confidence Interval (2-Sided) 95%
    -25.8429 to -0.1162
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.5287
    Estimation Comments
    14. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    48.29
    (2.37)
    51.04
    (4.05)
    57.51
    (4.33)
    47.87
    (1.75)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0199
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.2349
    Confidence Interval (2-Sided) 95%
    -0.4323 to -0.03745
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1003
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4577
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 2.60
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7417
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.9502
    Confidence Interval (2-Sided) 95%
    -6.6240 to 4.7236
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.8797
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7778
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.2580
    Confidence Interval (2-Sided) 95%
    -7.5129 to 10.0289
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.4523
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2411
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 8.5232
    Confidence Interval (2-Sided) 95%
    -5.7608 to 22.8073
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 7.2532
    Estimation Comments
    15. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    66.72
    (1.75)
    61.46
    (3.56)
    53.06
    (5.00)
    66.24
    (1.67)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0504
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value 0.1629
    Confidence Interval (2-Sided) 95%
    -0.00029 to 0.3261
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.08284
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.6942
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 1.45
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.5297
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 1.5241
    Confidence Interval (2-Sided) 95%
    -3.2469 to 6.2951
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.4216
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3155
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -3.7679
    Confidence Interval (2-Sided) 95%
    -11.1478 to 3.6120
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.7464
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1105
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -9.7558
    Confidence Interval (2-Sided) 95%
    -21.7515 to 2.2399
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.0920
    Estimation Comments
    16. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    35.97
    (1.92)
    41.22
    (3.86)
    48.82
    (5.91)
    36.80
    (1.77)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -.2979
    Confidence Interval (2-Sided) 95%
    -0.4465 to -0.1493
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.07538
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.4361
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 2.72
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.7297
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.9001
    Confidence Interval (2-Sided) 95%
    -6.0247 to 4.2246
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.6015
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.2868
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 4.2896
    Confidence Interval (2-Sided) 95%
    -3.6250 to 12.2043
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.0186
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.1516
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 9.0118
    Confidence Interval (2-Sided) 95%
    -3.3270 to 21.3505
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 6.2663
    Estimation Comments
    17. Primary Outcome
    Title Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses
    Description 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.
    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

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No RA
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    Measure Participants 126 42 20 170
    Mean (Standard Error) [units on TOPS scale]
    48.29
    (2.37)
    51.07
    (5.18)
    71.65
    (6.85)
    48.02
    (2.57)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group. The overall slope of the model (below) is reported as a continuous variable for time since injury. T
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value <0.0001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter Slope
    Estimated Value -0.9776
    Confidence Interval (2-Sided) 95%
    -1.2584 to -0.6967
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.1426
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, RA 8 - 14 Days From Injury, RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The time interaction component of the model is reported below.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.8548
    Comments
    Method Chi-squared
    Comments Degrees of Freedom: 3
    Method of Estimation Estimation Parameter Chi-Squared
    Estimated Value 0.78
    Confidence Interval (2-Sided) %
    to
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection RA Within 7 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.3882
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 3.3635
    Confidence Interval (2-Sided) 95%
    -4.3026 to 11.0296
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.8899
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection RA 8 - 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.9322
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value -0.5029
    Confidence Interval (2-Sided) 95%
    -12.1376 to 11.1317
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 5.9044
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection RA > 14 Days From Injury, No RA
    Comments A Linear Mixed Effects Model is utilized to examine the longitudinal progression of each outcome related to RA administration while adjusting for injury severity and length of stay of initial hospitalization for injury. The main treatment effect (RA group) is treated as a classification variable with the No RA group used as the reference group.
    Type of Statistical Test Superiority or Other
    Comments
    Statistical Test of Hypothesis p-Value 0.0233
    Comments
    Method Mixed Models Analysis
    Comments RA groups treated as classification variables with No RA group as reference.
    Method of Estimation Estimation Parameter Mean Difference (Net)
    Estimated Value 21.1166
    Confidence Interval (2-Sided) 95%
    2.8992 to 39.3341
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 9.2462
    Estimation Comments

    Adverse Events

    Time Frame 0, 1, 2, 3, 4, 5, 6, 9, 12, 15, 18, and 24 months after start of injury rehabilitation
    Adverse Event Reporting Description
    Arm/Group Title RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
    Arm/Group Description During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia within seven days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia at any point from day 8 to day 14 after date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which included first administration of regional anesthesia greater than 14 days from the date of injury. During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
    All Cause Mortality
    RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/126 (0%) 0/42 (0%) 0/20 (0%) 0/170 (0%)
    Other (Not Including Serious) Adverse Events
    RA Within 7 Days From Injury RA 8 - 14 Days From Injury RA > 14 Days From Injury No Regional Anesthesia (RA)
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/126 (0%) 0/42 (0%) 0/20 (0%) 0/170 (0%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Rollin M Gallagher, MD, MPH
    Organization Philadelphia Veterans Affairs Medical Center
    Phone (215) 823-5800 ext 4907
    Email Rollin.Gallagher@va.gov
    Responsible Party:
    VA Office of Research and Development
    ClinicalTrials.gov Identifier:
    NCT00431847
    Other Study ID Numbers:
    • D4506-I
    • NCT01710475
    First Posted:
    Feb 6, 2007
    Last Update Posted:
    May 15, 2017
    Last Verified:
    May 1, 2017