N/A
N=386
Regional Anesthesia Military Battlefield Pain Outcomes Study
Anxiety Disorders · Complex Regional Pain Syndrome Type II · Depressive Disorders · Post-Traumatic Stress Disorder · Substance Abuse
Bottom Line
View on ClinicalTrials.gov: NCT00431847 ↗Enrolled (actual)
386
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Neuropathic Pain Scale - Pain Intensity — 3; 3.44; 3.92; 3.04 units on the Neuropathic Pain Scale — p=<0.0001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Regional Anesthesia (Procedure); Standard Pain Management Protocol (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Sep 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neuropathic Pain Scale - Pain Intensity |
3; 3.44; 3.92; 3.04 | <0.0001 sig |
| PRIMARY Neuropathic Pain Scale - Overall Pain Quality |
1.90; 2.04; 2.13; 1.82 | <0.0001 sig |
| PRIMARY Neuropathic Pain Scale - Total Score |
2.35; 2.60; 2.80; 2.29 | <0.0001 sig |
| PRIMARY Brief Pain Inventory - Worst Pain |
4.54; 4.95; 5.83; 4.62 | <0.0001 sig |
| PRIMARY Brief Pain Inventory - Average Pain |
2.18; 2.45; 3.21; 2.45 | <0.0001 sig |
| PRIMARY Brief Pain Inventory - Pain Interference |
1.91; 2.03; 2.57; 1.88 | <0.0001 sig |
| PRIMARY Brief Pain Inventory - Treatment Relief |
67.53; 66.80; 58.58; 66.77 | 0.0002 sig |
| PRIMARY SF-36 Physical Component Summary |
40.30; 37.00; 31.51; 41.94 | <0.0001 sig |
| PRIMARY SF-36 Mental Component Summary |
52.47; 52.12; 49.90; 51.30 | <0.0001 sig |
| PRIMARY Post Traumatic Stress Disorder (PTSD) Total Severity |
27.99; 30.23; 25.62; 27.63 | 0.1938 |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance |
41.85; 43.57; 51.27; 40.62 | <.0001 sig |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction |
61.01; 56.29; 47.68; 58.77 | 0.0016 sig |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS):Life Control |
75.82; 68.02; 58.52; 73.76 | 0.6602 |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability |
48.29; 51.04; 57.51; 47.87 | 0.0199 sig |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes |
66.72; 61.46; 53.06; 66.24 | 0.0504 |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms |
35.97; 41.22; 48.82; 36.80 | 0.001 sig |
| PRIMARY Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses |
48.29; 51.07; 71.65; 48.02 | <0.0001 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00431847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.