Recruiting
Phase 2

Stellate Ganglion Block & Prolonged Exposure

Sponsor:

The University of Texas Health Science Center at San Antonio

Code:

NCT05889741

Conditions

Stress Disorders, Post-Traumatic

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Ropivacaine injection

Normal saline

Study Details

Brief summary:

The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.

Conditions

Stress Disorders, Post-Traumatic

Study ID

NCT05889741

Start date

Feb 26, 2024

Status verified date

Aug, 2025

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

1. Active duty and retired military service members ages 18-65 years
2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale
3. Able to speak and read English (due to standardization of outcome measures)
4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at a military treatment facility (MTF) where the stellate ganglion block will be placed.

Exclusion Criteria:

1. Current suicidal ideation severe enough to warrant immediate attention (as determined by the Depressive Symptoms Index - Suicidality Subscale and the Self-Injurious Thoughts and Behaviors Interview short form) and corroborated by a clinical risk assessment by a credentialed provider.
2. Current manic episode or psychotic symptoms requiring immediate stabilization or hospitalization (as determined by clinical judgment)
3. Symptoms of moderate to severe substance use (to include alcohol) warranting immediate intervention based on clinical judgment.
4. Other psychiatric disorders severe enough to warrant designation as the primary disorder as determined by clinician judgment
5. Pregnancy or breastfeeding
6. Current anticoagulant use
7. History of bleeding disorder
8. Infection or mass at injection site
9. Myocardial infarction within 6 months of procedure
10. Pathologic bradycardia or irregularities of heart rate or rhythm
11. Symptomatic hypotension
12. Phrenic or laryngeal nerve palsy
13. History of glaucoma
14. Uncontrolled seizure disorder
15. History of allergy to local anesthetics
16. Current use of Class III antiarrhythmics

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Stellate Ganglion Block

One time administration of a stellate ganglion block

placebo comparator: Sham SGB

One time administration

Interventions

Ropivacaine injection

6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion

Normal saline

6.5cc of Normal Saline one time into the stellate ganglion.

Primary outcome measure

  • Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5) [ Time Frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments ]
  • Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5) [ Time Frame: Baseline and at 1-month, 3-month, and 6-month follow-up assessments ]

Central Contacts and Locations

Central contacts

Locations

Carl R. Darnall Army Medical Center

Recruiting

Fort Hood, Texas, United States, 76544

Contacts

Principal Investigator:

Caleb Dickinson, DO

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Principal Investigator:

Alan Peterson, PhD

More Information

Sponsor

The University of Texas Health Science Center at San Antonio

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Keywords

  • SGB
  • Military

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center at San Antonio on 2025-09-04.