Trial Outcomes & Findings for Regional Anesthesia Military Battlefield Pain Outcomes Study (NCT NCT00431847)

NCT ID: NCT00431847

Last Updated: 2017-05-15

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 386 participants
• Primary outcome timeframe: 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
• Results posted on: 2017-05-15

Participant Flow

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.

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.

Participant milestones

Measure	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
Overall Study STARTED	132	45	24	184	1
Overall Study COMPLETED	126	42	20	170	0
Overall Study NOT COMPLETED	6	3	4	14	1

Reasons for withdrawal

Measure	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
Overall Study completion of less than two study visits	6	3	4	14	0
Overall Study Protocol Violation	0	0	0	0	1

Baseline Characteristics

Regional Anesthesia Military Battlefield Pain Outcomes Study

Baseline characteristics by cohort

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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) n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.	Total n=358 Participants Total of all reporting groups
Age, Continuous	28.20 years STANDARD_DEVIATION 6.30 • n=5 Participants	26.68 years STANDARD_DEVIATION 4.80 • n=7 Participants	29.08 years STANDARD_DEVIATION 8.97 • n=5 Participants	28.15 years STANDARD_DEVIATION 7.87 • n=4 Participants	28.04 years STANDARD_DEVIATION 7.10 • n=21 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	3 Participants n=21 Participants
Sex: Female, Male Male	126 Participants n=5 Participants	41 Participants n=7 Participants	20 Participants n=5 Participants	168 Participants n=4 Participants	355 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	8 Participants n=7 Participants	4 Participants n=5 Participants	19 Participants n=4 Participants	45 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	112 Participants n=5 Participants	34 Participants n=7 Participants	16 Participants n=5 Participants	151 Participants n=4 Participants	313 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	9 Participants n=21 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	6 Participants n=4 Participants	14 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	12 Participants n=4 Participants	19 Participants n=21 Participants
Race (NIH/OMB) White	101 Participants n=5 Participants	31 Participants n=7 Participants	17 Participants n=5 Participants	129 Participants n=4 Participants	278 Participants n=21 Participants
Race (NIH/OMB) More than one race	12 Participants n=5 Participants	6 Participants n=7 Participants	1 Participants n=5 Participants	17 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Education High School/GED	47 participants n=5 Participants	18 participants n=7 Participants	8 participants n=5 Participants	74 participants n=4 Participants	147 participants n=21 Participants
Education Some College	47 participants n=5 Participants	18 participants n=7 Participants	9 participants n=5 Participants	72 participants n=4 Participants	146 participants n=21 Participants
Education Bachelor's Degree or Higher	32 participants n=5 Participants	6 participants n=7 Participants	3 participants n=5 Participants	24 participants n=4 Participants	65 participants n=21 Participants
Marital Status Never Married	51 participants n=5 Participants	19 participants n=7 Participants	7 participants n=5 Participants	89 participants n=4 Participants	166 participants n=21 Participants
Marital Status Married or Living w/Partner	70 participants n=5 Participants	22 participants n=7 Participants	13 participants n=5 Participants	67 participants n=4 Participants	172 participants n=21 Participants
Marital Status Separated/Divorced	5 participants n=5 Participants	1 participants n=7 Participants	0 participants n=5 Participants	14 participants n=4 Participants	20 participants n=21 Participants
Number of Deployments, Continuous	2.13 deployments STANDARD_DEVIATION 1.27 • n=5 Participants	1.80 deployments STANDARD_DEVIATION 0.90 • n=7 Participants	2.40 deployments STANDARD_DEVIATION 2.54 • n=5 Participants	1.85 deployments STANDARD_DEVIATION 1.05 • n=4 Participants	1.97 deployments STANDARD_DEVIATION 1.25 • n=21 Participants
Injury Severity Score (ISS)	17.31 units on a scale STANDARD_DEVIATION 8.56 • n=5 Participants	19.74 units on a scale STANDARD_DEVIATION 11.88 • n=7 Participants	24.65 units on a scale STANDARD_DEVIATION 12.59 • n=5 Participants	18.07 units on a scale STANDARD_DEVIATION 11.57 • n=4 Participants	18.37 units on a scale STANDARD_DEVIATION 10.79 • n=21 Participants
Length of Initial Hospital Stay	41.14 months STANDARD_DEVIATION 30.54 • n=5 Participants	47.45 months STANDARD_DEVIATION 33.74 • n=7 Participants	59.90 months STANDARD_DEVIATION 47.64 • n=5 Participants	27.95 months STANDARD_DEVIATION 30.72 • n=4 Participants	36.69 months STANDARD_DEVIATION 33.35 • n=21 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Neuropathic Pain Scale - Pain Intensity	3 units on the Neuropathic Pain Scale Standard Error 0.16	3.44 units on the Neuropathic Pain Scale Standard Error 0.3	3.92 units on the Neuropathic Pain Scale Standard Error 0.45	3.04 units on the Neuropathic Pain Scale Standard Error 0.15

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Neuropathic Pain Scale - Overall Pain Quality	1.90 units on the Neuropathic Pain Scale Standard Error 0.11	2.04 units on the Neuropathic Pain Scale Standard Error 0.20	2.13 units on the Neuropathic Pain Scale Standard Error 0.27	1.82 units on the Neuropathic Pain Scale Standard Error 0.10

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Neuropathic Pain Scale - Total Score	2.35 units on the Neuropathic Pain Scale Standard Error 0.12	2.60 units on the Neuropathic Pain Scale Standard Error 0.22	2.80 units on the Neuropathic Pain Scale Standard Error 0.31	2.29 units on the Neuropathic Pain Scale Standard Error 0.11

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Brief Pain Inventory - Worst Pain	4.54 units on the Brief Pain Inventory Scale Standard Error 0.18	4.95 units on the Brief Pain Inventory Scale Standard Error 0.36	5.83 units on the Brief Pain Inventory Scale Standard Error 0.44	4.62 units on the Brief Pain Inventory Scale Standard Error 0.19

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Brief Pain Inventory - Average Pain	2.18 units on the Brief Pain Inventory Scale Standard Error 0.13	2.45 units on the Brief Pain Inventory Scale Standard Error 0.23	3.21 units on the Brief Pain Inventory Scale Standard Error 0.42	2.45 units on the Brief Pain Inventory Scale Standard Error 0.13

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Brief Pain Inventory - Pain Interference	1.91 units on the Brief Pain Inventory Scale Standard Error 0.15	2.03 units on the Brief Pain Inventory Scale Standard Error 0.25	2.57 units on the Brief Pain Inventory Scale Standard Error 0.46	1.88 units on the Brief Pain Inventory Scale Standard Error 0.14

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Brief Pain Inventory - Treatment Relief	67.53 percentage of pain relief Standard Error 2.39	66.80 percentage of pain relief Standard Error 3.04	58.58 percentage of pain relief Standard Error 4.88	66.77 percentage of pain relief Standard Error 1.86

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
SF-36 Physical Component Summary	40.30 t-score Standard Error 0.96	37.00 t-score Standard Error 1.72	31.51 t-score Standard Error 2.05	41.94 t-score Standard Error 0.92

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
SF-36 Mental Component Summary	52.47 t-score Standard Error 1.11	52.12 t-score Standard Error 1.84	49.90 t-score Standard Error 2.94	51.30 t-score Standard Error 0.82

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Post Traumatic Stress Disorder (PTSD) Total Severity	27.99 units on the PCL scale Standard Error 1.10	30.23 units on the PCL scale Standard Error 1.98	25.62 units on the PCL scale Standard Error 2.00	27.63 units on the PCL scale Standard Error 0.87

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS): Fear Avoidance	41.85 units on TOPS scale Standard Error 2.07	43.57 units on TOPS scale Standard Error 3.65	51.27 units on TOPS scale Standard Error 6.29	40.62 units on TOPS scale Standard Error 1.91

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS): Health Care Satisfaction	61.01 units on TOPS scale Standard Error 1.80	56.29 units on TOPS scale Standard Error 3.54	47.68 units on TOPS scale Standard Error 4.67	58.77 units on TOPS scale Standard Error 1.68

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS):Life Control	75.82 units on TOPS scale Standard Error 1.92	68.02 units on TOPS scale Standard Error 4.15	58.52 units on TOPS scale Standard Error 5.76	73.76 units on TOPS scale Standard Error 1.70

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS): Observed Family Social Disability	48.29 units on TOPS scale Standard Error 2.37	51.04 units on TOPS scale Standard Error 4.05	57.51 units on TOPS scale Standard Error 4.33	47.87 units on TOPS scale Standard Error 1.75

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS): Patient Satisfaction With Outcomes	66.72 units on TOPS scale Standard Error 1.75	61.46 units on TOPS scale Standard Error 3.56	53.06 units on TOPS scale Standard Error 5.00	66.24 units on TOPS scale Standard Error 1.67

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS): Pain Symptoms	35.97 units on TOPS scale Standard Error 1.92	41.22 units on TOPS scale Standard Error 3.86	48.82 units on TOPS scale Standard Error 5.91	36.80 units on TOPS scale Standard Error 1.77

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	RA Within 7 Days From Injury n=126 Participants 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 n=42 Participants 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 n=20 Participants 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 RA n=170 Participants During initial hospital admission for combat injury, participant received standard pain management treatment which did not include regional anesthesia.
Treatment Outcomes in Pain Survey (TOPS): Solicitous Responses	48.29 units on TOPS scale Standard Error 2.37	51.07 units on TOPS scale Standard Error 5.18	71.65 units on TOPS scale Standard Error 6.85	48.02 units on TOPS scale Standard Error 2.57

Adverse Events

RA Within 7 Days From Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RA 8 - 14 Days From Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

RA > 14 Days From Injury

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Regional Anesthesia (RA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rollin M Gallagher, MD, MPH

Philadelphia Veterans Affairs Medical Center

Phone: (215) 823-5800

Email: Rollin.Gallagher@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place