Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Effectiveness

• Sponsor: RTI International (Other)
• Overall Status: Completed
• CT.gov ID: NCT03077919
• Collaborator: Womack Army Medical Center (U.S. Fed), Tripler Army Medical Center (U.S. Fed), Landstuhl Regional Medical Center (U.S. Fed)
• Enrollment: 113
• Locations: 3
• Arms: 2
• Actual Duration (Months): 24.5
• Patients Per Site: 37.7
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

This is a multisite, randomized, blinded, sham-procedure-controlled study to evaluate the efficacy of right-sided stellate ganglion block (SGB) on the acute symptomatology of Post traumatic Stress Disorder (PTSD), evaluated by the Clinician-Administered PTSD Scale (CAPS-5) clinical interview at pre-treatment and at 8 weeks. This entry describes the effectiveness study.The acceptability study is described in a separate entry.

Condition or Disease	Intervention/Treatment	Phase
PostTraumatic Stress Disorder	Drug: Ropivacaine; Drug: Sham treatment	N/A

Detailed Description

Study intervention will be administered at week 0 and at week 2. Injections will be performed under ultrasound visualization. The study medication will be either 7-10 mL 0.5% ropivacaine injected ventral to the right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia at the level of the C6 anterior tubercle (landmarks for the stellate ganglion) (active study medication) or 1-2 mL preservative free normal saline injected anterolateral to the anterior tubercle of C6 (sham procedure). The participant will not be informed which treatment he or she has received and the interaction of the participant and treating physician will be scripted as much as possible. Following the intervention, the treating physician should have no further contact with the participant except as required for participant safety.

Participants will be evaluated for posttraumatic stress disorder (PTSD) symptomatology prior to week 0 and at 8 weeks using the Diagnostic and Statistical Manual (DSM-5) Clinician-Administered PTSD Scale (CAPS-5). They will complete the PTSD Checklist for DSM-5 (PCL-5), the PTSD Checklist - Civilian Version (PCL-C), and the Mini-international Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 0, 2, 4, 6, and 8 weeks; they also will complete the M.I.N.I.-Plus items at screening. The 12 item short form survey (SF-12), generalized anxiety disorder 7-item (GAD-7), patient health questionnaire (PHQ-9), K6, Alcohol Use Disorder Identification Test (AUDIT-C/AUDIT), and a short pain scale will be completed at weeks 0, 4, and 8.

Data collected at baseline and 8 weeks will be the primary focus of data analysis. Data collected at other time points will be analyzed as appropriate.

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will be centrally randomized to 2:1 active:sham SGB and will be evaluated at Womack Army Medical Center in North Carolina, Tripler Army Medical Center in Hawaii, and Landstuhl Regional Medical Center in Germany. Randomization will be stratified by site so that each will have a 2:1 active:sham ratio. The target population includes active-duty service members and study duration is 10 weeks in the clinical effectiveness trial for which an enrollment of 240 participants is planned.Participants will be centrally randomized to 2:1 active:sham SGB and will be evaluated at Womack Army Medical Center in North Carolina, Tripler Army Medical Center in Hawaii, and Landstuhl Regional Medical Center in Germany. Randomization will be stratified by site so that each will have a 2:1 active:sham ratio. The target population includes active-duty service members and study duration is 10 weeks in the clinical effectiveness trial for which an enrollment of 240 participants is planned.
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Sham-procedure-controlled, Blinded Study to Evaluate the Effectiveness and Acceptability of Right-sided Stellate Ganglion Block for Treatment of Posttraumatic Stress Disorder Symptoms
• Actual Study Start Date: May 25, 2016
• Actual Primary Completion Date: Jun 9, 2018
• Actual Study Completion Date: Jun 9, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Stellate Ganglion Block (SGB) 7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion).	Drug: Ropivacaine; 0.5% ropivacaine; Other Names: Naropin
Sham Comparator: Sham Treatment 1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6.	Drug: Sham treatment; preservative-free normal saline; Other Names: saline

Outcome Measures

Primary Outcome Measures

1. Clinician Administered PTSD Score (CAPS-5) TSSS [Baseline, 8-weeks]

   ≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD).

Secondary Outcome Measures

1. PTSD Checklist (PCL-5) [Baseline, 8-weeks]

   to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline; On the PCL 5, the range is 0 to 80, with higher scores indicating worse PTSD symptomatology.

2. PTSD Checklist Civilian (PCL-C) [Baseline, 8-weeks]

   to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline; The total symptom severity score ranges from 17 to 85. The higher the score, the more severe the PTSD symptomatology

3. Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items [Baseline, 8-weeks]

   to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 8 weeks. The higher the score, the more severe the pathology. If an individual answers "yes" to any of seven initial questions concerning suicidal ideation in the past two months, they are asked an additional four questions regarding current suicidal ideation. Any positive answer on these four current questions triggers an automated alert system.

4. Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C) [Baseline, 8-weeks]

   to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks. Based on a scale of 0 to 12, a score of 4 or greater is considered positive in males, while a score of 3 or more is positive among females.

5. Kessler Psychiatric Distress Scale (K6) [Baseline, 8-weeks]

   to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Kessler Psychiatric Distress Scale (K6) at 8 weeks. Scores range from 0 to 24 resulting from 6 items administered on a scale of 0 to 4, with a score of 13 or greater indicative of serious psychological distress in the U.S. general population.

6. The Patient Health Questionnaire (PHQ-9) [Baseline, 8-weeks]

   to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by The Patient Health Questionnaire (PHQ-9) at 8 weeks; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology.

7. Generalized Anxiety Disorder 7-item Survey (GAD-7) [Baseline, 8-weeks]

   to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at 8 weeks;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology.

8. 12-item Short Form Survey (SF-12) of Physical Functioning [Baseline, 8-weeks]

   to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by 12-item Short Form Survey (SF-12) at 8 weeks. The score mean is 50; standard deviation of 10. The physical component score (PCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better physical health. The United States population average PCS-12 is 50 points.

9. Short Pain Scale [Baseline, 8-weeks]

   to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Pain Scale at 8 weeks; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain.

10. Current Medications [Baseline, 8-weeks]

    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by a decrease in Current Medications at 8 weeks; in order to assess the potential impact of medication use concurrent with study participation, information on prescription psychotropics (including stimulants, anxiolytics, and antidepressants), anticonvulsants, antipsychotics, anticholinergic drugs, opioids, nicotine, sleeping medications, antihypertensives, and sympathomimetics/sympatholytics was collected.

11. 12 Item Short Form Survey (SF-12) of Mental Functioning [Baseline, 8-weeks]

    to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Mental Functioning Scale at 8 weeks. The score mean is 50; standard deviation of 10. The mental component score (MCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better mental health. The United States population average MCS-12 is 50 points.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Member of the Army on active duty status

• Personal access to Internet

• Anticipated stable assignment to installation for at least 2 months

• Stable dosing for ≥3 months, if receiving psychotropic medications

• Prior to enrollment, offered PTSD treatment using A-level modality (as defined by U.S. Army Medical Command (MEDCOM) policy 14-094; 18 Dec 2014).

• PTSD Checklist - Civilian (PCL-C) score of 32 or greater at screening

• Acceptable clinically indicated preoperative laboratory studies, per standard site-specific protocols

Exclusion Criteria:

• Prior Stellate Ganglion Block (SGB)

• Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)

• Pregnancy (evaluated by urine test pre-procedure)

• Current anticoagulant use

• History of a bleeding disorder

• Infection or mass at injection site

• Myocardial infarction within 6 months of procedure

• Phrenic or laryngeal nerve palsy (hoarseness)

• History of glaucoma

• History of schizophrenia, other psychotic disorder, bipolar disorder, or personality disorder (axis 2)

• Moderate or severe traumatic brain injury

• Symptoms of moderate to severe substance use disorder in past 30 days

• Suicidal ideation in the past 2 months, documented by the M.I.N.I.-Plus Suicidality Items

• Any ongoing other major life stressor or condition not listed here that the site Investigator believes clearly would place the participant at risk for injury or a poor outcome

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tripler Army Medical Center (TAMC)	Honolulu	Hawaii	United States	96859
2	Womack Army Medical Center (WAMC)	Fort Bragg	North Carolina	United States	28310
3	Landstuhl Regional Medical Center (LRMC)	Landstuhl		Germany	66849

Sponsors and Collaborators

• RTI International
• Womack Army Medical Center
• Tripler Army Medical Center
• Landstuhl Regional Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Mar 3, 2018
• Statistical Analysis Plan - Jul 12, 2018

More Information

Publications

None provided.

• Responsible Party: RTI International
• ClinicalTrials.gov Identifier: NCT03077919
• Other Study ID Numbers: SGB-201
• First Posted: Mar 13, 2017
• Last Update Posted: May 13, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by RTI International: Posttraumatic Stress Disorder; Generalized Anxiety Disorder; Depression; Distress; Alcohol Use; Pain
• Additional relevant MeSH terms: Disease; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Ropivacaine

Study Results

Participant Flow

Recruitment Details	123 participants screened eligible and completed the baseline CAPS-5
Pre-assignment Detail	113 participants were randomized to treatment/sham and underwent the study procedure at Week 0 and Week 2.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Period Title: Overall Study
STARTED	74	39
Week 2 Visit	74	39
Week 4 Visit	73	38
Week 6 Visit	73	38
Week 8 Visit	71	38
Final CAPS	70	38
COMPLETED	70	38
NOT COMPLETED	4	1

Baseline Characteristics

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment	Total
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline	Total of all reporting groups
Overall Participants	74	39	113
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	74 100%	39 100%	113 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	10 13.5%	3 7.7%	13 11.5%
Male	64 86.5%	36 92.3%	100 88.5%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Marital Status (Count of Participants)
Married	67 90.5%	33 84.6%	100 88.5%
Unmarried	7 9.5%	6 15.4%	13 11.5%
Military Rank (Count of Participants)
Junior Enlisted	3 4.1%	3 7.7%	6 5.3%
Non-commissioned Officer	27 36.5%	11 28.2%	38 33.6%
Senior Enlisted	28 37.8%	19 48.7%	47 41.6%
Warrant Officer	5 6.8%	3 7.7%	8 7.1%
Commissioned Officer	11 14.9%	3 7.7%	14 12.4%
Met CAPS-5 Criteria for PTSD (Count of Participants)
Count of Participants [Participants]	60 81.1%	31 79.5%	91 80.5%

Outcome Measures

1. Primary Outcome

Title	Clinician Administered PTSD Score (CAPS-5) TSSS
Description	≥ 10 point mean Clinician-Administered PTSD Scale for DSM 5 (CAPS 5) total symptom severity scores (TSSS) improvement from baseline to 8 weeks, adjusted for site and baseline TSSS (planned a priori), following paired SGB at 0 and 2 weeks. On the CAPS 5, the range for TSSS is 0 to 80, with higher scores indicating worse PTSD symptomatology. The CAPS-5 is a 30-item structured interview, administered by a credentialed behavioral health practitioner, that corresponds to the DSM-5 criteria for PTSD (Weathers et al. 2013, The Clinician Administered PTSD Scale for DSM-5, Boston MA: The National Center for PTSD).
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Multiple imputation performed for missing data; Mean change - Adjusted for site and baseline CAPS TSSS; adjusted mean reduction in TSSS from baseline to week 8 by treatment group from per-protocol analysis and secondary analysis among those who fulfilled CAPS 5 diagnostic criteria for PTSD at baseline were consistent with those from ITT analyses

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	37.61 (11.13)	39.82 (14.23)
8-week follow-up	25.67 (14.13)	33.68 (15.60)

2. Secondary Outcome

Title	PTSD Checklist (PCL-5)
Description	to evaluate symptoms measured by PTSD Checklist (PCL-5) at baseline; On the PCL 5, the range is 0 to 80, with higher scores indicating worse PTSD symptomatology.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	41.54 (14.03)	43.23 (18.13)
8-week follow-up	29.49 (19.29)	38.11 (18.23)

3. Secondary Outcome

Title	PTSD Checklist Civilian (PCL-C)
Description	to evaluate symptoms measured by PTSD Checklist Civilian (PCL-C) at baseline; The total symptom severity score ranges from 17 to 85. The higher the score, the more severe the PTSD symptomatology
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	53.30 (13.64)	54.95 (15.67)
8-week follow-up	42.41 (17.47)	50.65 (17.04)

4. Secondary Outcome

Title	Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Mini-International Neuropsychiatric Interview (M.I.N.I.-Plus) Suicidality Items at 8 weeks. The higher the score, the more severe the pathology. If an individual answers "yes" to any of seven initial questions concerning suicidal ideation in the past two months, they are asked an additional four questions regarding current suicidal ideation. Any positive answer on these four current questions triggers an automated alert system.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	0	0
8-week follow-up	0	0

5. Secondary Outcome

Title	Alcohol Use Disorders Identification Test (AUDIT/AUDIT-C)
Description	to evaluate symptoms measured by the Alcohol Use Disorders Identification Test at 8 weeks. Based on a scale of 0 to 12, a score of 4 or greater is considered positive in males, while a score of 3 or more is positive among females.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	2.74 (2.64)	3.18 (4.26)
8-week follow-up	2.72 (2.71)	2.62 (3.80)

6. Secondary Outcome

Title	Kessler Psychiatric Distress Scale (K6)
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Kessler Psychiatric Distress Scale (K6) at 8 weeks. Scores range from 0 to 24 resulting from 6 items administered on a scale of 0 to 4, with a score of 13 or greater indicative of serious psychological distress in the U.S. general population.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	10.08 (5.55)	10.33 (6.01)
8-week follow-up	7.80 (6.41)	10.00 (6.25)

7. Secondary Outcome

Title	The Patient Health Questionnaire (PHQ-9)
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by The Patient Health Questionnaire (PHQ-9) at 8 weeks; On the PHQ-9, the range is 0 to 27, with higher scores indicating worse depression symptomatology.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	12.57 (6.05)	12.69 (6.61)
8-week follow-up	8.68 (6.02)	11.76 (6.25)

8. Secondary Outcome

Title	Generalized Anxiety Disorder 7-item Survey (GAD-7)
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by Generalized Anxiety Disorder 7-item survey (GAD-7) at 8 weeks;On the GAD-7, the range is 0 to 21, with higher scores indicating worse anxiety symptomatology.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	12.39 (5.35)	12.49 (5.50)
8-week follow-up	8.11 (6.02)	11.19 (6.38)

9. Secondary Outcome

Title	12-item Short Form Survey (SF-12) of Physical Functioning
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by 12-item Short Form Survey (SF-12) at 8 weeks. The score mean is 50; standard deviation of 10. The physical component score (PCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better physical health. The United States population average PCS-12 is 50 points.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	41.04 (8.16)	42.01 (7.87)
8-week follow-up	43.43 (8.33)	41.28 (8.18)

10. Secondary Outcome

Title	Short Pain Scale
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Pain Scale at 8 weeks; On the pain rating, the range is 0 to 10, with higher scores indicating worse pain.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

[*] Analysis Population Description Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	4.61 (2.40)	4.95 (2.21)
8-week follow-up	4.10 (2.51)	4.86 (2.30)

11. Secondary Outcome

Title	Current Medications
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by a decrease in Current Medications at 8 weeks; in order to assess the potential impact of medication use concurrent with study participation, information on prescription psychotropics (including stimulants, anxiolytics, and antidepressants), anticonvulsants, antipsychotics, anticholinergic drugs, opioids, nicotine, sleeping medications, antihypertensives, and sympathomimetics/sympatholytics was collected.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	1	2
8-week follow-up	1	1

12. Secondary Outcome

Title	12 Item Short Form Survey (SF-12) of Mental Functioning
Description	to evaluate whether right-sided stellate ganglion block (SGB) performed at 0 and 2 weeks will result in improvement in symptoms measured by the Short Mental Functioning Scale at 8 weeks. The score mean is 50; standard deviation of 10. The mental component score (MCS-12) is one of two summary scores reported for the SF-12. Higher scores indicate better mental health. The United States population average MCS-12 is 50 points.
Time Frame	Baseline, 8-weeks

Outcome Measure Data

Analysis Population Description

Adjusted for site, gender, age, visit, and interaction between visit and treatment.

Arm/Group Title	Stellate Ganglion Block (SGB)	Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine	1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
Measure Participants	74	39
Baseline	41.24 (11.32)	40.16 (9.84)
8-week follow-up	42.83 (10.22)	40.17 (9.50)

Adverse Events

Time Frame	Adverse event data was collected for eight weeks.
Arm/Group Title	Stellate Ganglion Block (SGB)		Sham Treatment
Arm/Group Description	7-10 mL 0.5% ropivacaine injected under ultrasound visualization ventral to right longus coli muscle (around and into the ventral fascia) and into the longus coli immediately dorsal to the presumed ventral fascia, at the level of the C6 anterior tubercle (landmarks for stellate ganglion). Ropivacaine: 0.5% ropivacaine		1-2 mL preservative-free normal saline, injected under ultrasound visualization anterolateral to right anterior tubercle of C6. Sham treatment: preservative-free normal saline
All Cause Mortality
	Stellate Ganglion Block (SGB)		Sham Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/39 (0%)
Serious Adverse Events
	Stellate Ganglion Block (SGB)		Sham Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/74 (0%)		0/39 (0%)
Other (Not Including Serious) Adverse Events
	Stellate Ganglion Block (SGB)		Sham Treatment
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/74 (6.8%)		1/39 (2.6%)
Cardiac disorders
Self-resolving episode of bradycardia (30-second duration; minimum heart rate of 32)	1/74 (1.4%)	1	0/39 (0%)	0
Endocrine disorders
Detection of nodule or cyst (< 1 cm) in thyroid gland	1/74 (1.4%)	1	0/39 (0%)	0
Nervous system disorders
Vasovagal syncope with insertion of the IV	1/74 (1.4%)	1	0/39 (0%)	0
Report of mild, relative increase in pre-existing right tinnitus	0/74 (0%)	0	1/39 (2.6%)	1
Respiratory, thoracic and mediastinal disorders
Temporary irritation of larynx which resulted in coughing	1/74 (1.4%)	1	0/39 (0%)	0
Skin and subcutaneous tissue disorders
Pain and redness at injection site	1/74 (1.4%)	1	0/39 (0%)	0

Limitations/Caveats

Treating physicians unblinded; Horner syndrome noticeable; specific population re psychotropic usage, administrative evaluations, TBI history; overall PTSD symptom severity low-moderate; a number of participants still fulfil PTSD criteria at 8 weeks.

More Information

Certain Agreements

All Principal Investigators ARE 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.