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Regional Anesthesia Military Battlefield Pain Outcomes Study (RAMBPOS)

This study has been completed.
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Brooke Army Medical Center
University of Pennsylvania
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00431847
First received: February 2, 2007
Last updated: May 4, 2017
Last verified: May 2017
Results First Received: February 8, 2016  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Conditions: Anxiety Disorders
Complex Regional Pain Syndrome Type II
Depressive Disorders
Post-Traumatic Stress Disorder
Substance Abuse
Interventions: Procedure: Regional Anesthesia
Procedure: Standard Pain Management Protocol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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 Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups
  Description
RA Within 7 Days From Injury 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.
RA 8 - 14 Days From 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.
RA > 14 Days From 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.
No Regional Anesthesia (RA) During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Unknown Treatment Status No patient data on exposure to Regional Anesthesia

Participant Flow:   Overall Study
    RA Within 7 Days From Injury   RA 8 - 14 Days From Injury   RA > 14 Days From Injury   No Regional Anesthesia (RA)   Unknown Treatment Status
STARTED   132   45   24   184   1 
COMPLETED   126 [1]   42 [1]   20 [1]   170 [1]   0 
NOT COMPLETED   6   3   4   14   1 
completion of less than two study visits                6                3                4                14                0 
Protocol Violation                0                0                0                0                1 
[1] All participants with at least two study visits were included in analysis.



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
RA Within 7 Days From Injury 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.
RA 8 - 14 Days From 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.
RA > 14 Days From 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.
No Regional Anesthesia (RA) During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Total Total of all reporting groups

Baseline Measures
   RA Within 7 Days From Injury   RA 8 - 14 Days From Injury   RA > 14 Days From Injury   No Regional Anesthesia (RA)   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   42   20   170   358 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.20  (6.30)   26.68  (4.80)   29.08  (8.97)   28.15  (7.87)   28.04  (7.10) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      0   0.0%      1   2.4%      0   0.0%      2   1.2%      3   0.8% 
Male      126 100.0%      41  97.6%      20 100.0%      168  98.8%      355  99.2% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
         
Hispanic or Latino      14  11.1%      8  19.0%      4  20.0%      19  11.2%      45  12.6% 
Not Hispanic or Latino      112  88.9%      34  81.0%      16  80.0%      151  88.8%      313  87.4% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
         
American Indian or Alaska Native      2   1.6%      1   2.4%      0   0.0%      6   3.5%      9   2.5% 
Asian      5   4.0%      3   7.1%      0   0.0%      6   3.5%      14   3.9% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5   4.0%      0   0.0%      2  10.0%      12   7.1%      19   5.3% 
White      101  80.2%      31  73.8%      17  85.0%      129  75.9%      278  77.7% 
More than one race      12   9.5%      6  14.3%      1   5.0%      17  10.0%      36  10.1% 
Unknown or Not Reported      1   0.8%      1   2.4%      0   0.0%      0   0.0%      2   0.6% 
Education 
[Units: Participants]
         
High School/GED   47   18   8   74   147 
Some College   47   18   9   72   146 
Bachelor's Degree or Higher   32   6   3   24   65 
Marital Status 
[Units: Participants]
         
Never Married   51   19   7   89   166 
Married or Living w/Partner   70   22   13   67   172 
Separated/Divorced   5   1   0   14   20 
Number of Deployments, Continuous 
[Units: Deployments]
Mean (Standard Deviation)
 2.13  (1.27)   1.80  (0.90)   2.40  (2.54)   1.85  (1.05)   1.97  (1.25) 
Injury Severity Score (ISS) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 17.31  (8.56)   19.74  (11.88)   24.65  (12.59)   18.07  (11.57)   18.37  (10.79) 
[1] Injury Severity Scores (ISS): ISS is a scale to evaluate anatomic injury severity following trauma that ranges from 0 to 75, with 75 indicating the greatest severity. An Abbreviated Injury Scale (AIS) score is allocated to the six body regions (Head, Face, Chest, Abdomen, Extremities, and External). The highest AIS score in each body region is used. The 3 most severely injured body regions scores are squared and summed to produce the ISS. The ISS correlates linearly with mortality, morbidity, and hospital stay.
Length of Initial Hospital Stay 
[Units: Months]
Mean (Standard Deviation)
 41.14  (30.54)   47.45  (33.74)   59.90  (47.64)   27.95  (30.72)   36.69  (33.35) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Neuropathic Pain Scale - Pain Intensity   [ 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 ]

2.  Primary:   Neuropathic Pain Scale - Overall Pain Quality   [ 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 ]

3.  Primary:   Neuropathic Pain Scale - Total Score   [ 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 ]

4.  Primary:   Brief Pain Inventory - Worst Pain   [ 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 ]

5.  Primary:   Brief Pain Inventory - Average Pain   [ 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 ]

6.  Primary:   Brief Pain Inventory - Pain Interference   [ 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 ]

7.  Primary:   Brief Pain Inventory - Treatment 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 ]

8.  Primary:   SF-36 Physical Component Summary   [ 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 ]

9.  Primary:   SF-36 Mental Component Summary   [ 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 ]

10.  Primary:   Post Traumatic Stress Disorder (PTSD) Total Severity   [ 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 ]

11.  Primary:   Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance   [ 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 ]

12.  Primary:   Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction   [ 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 ]

13.  Primary:   Treatment Outcomes in Pain Survey (TOPS):Life Control   [ 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 ]

14.  Primary:   Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability   [ 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 ]

15.  Primary:   Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes   [ 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 ]

16.  Primary:   Treatment Outcomes in Pain Survey (TOPS): Pain 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 ]

17.  Primary:   Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses   [ 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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: Rollin.Gallagher@va.gov



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00431847     History of Changes
Obsolete Identifiers: NCT01710475
Other Study ID Numbers: D4506-I
Study First Received: February 2, 2007
Results First Received: February 8, 2016
Last Updated: May 4, 2017