Stellate Ganglion Block for PTSD

Summary

Posttraumatic Stress Disorder (PTSD) is a debilitating condition that affects about 15% of Veterans. Current treatments for Veterans with PTSD include medications and psychological therapies that help to process and desensitize to traumatic events. While effective for many, these treatments do not work for all patients, and many may refuse them. Stellate Ganglion Block (SGB), established to treat pain and other conditions, has shown promise for PTSD: early small studies show it may work fast and greatly reduce symptoms. However, data from larger studies are not clear about SGBs effects. A definitive trial is needed, especially for the Veteran population. This large, well-powered, randomized, sham-controlled trial of SGB for PTSD will assess the short-term efficacy of this intervention, the durability of the effects and the safety of the treatment. Additionally, this study will provide critically important information about biological effects of SGB and potential mechanisms of action. This timely study is critical to help VA clinicians better decide about the merits of SGB for PTSD.

Conditions

• Post-traumatic Stress Disorder

Interventions

PROCEDURE

Stellate Ganglion Block

After procedure informed consent, the procedure will be done using an ultrasound guided technique with a high frequency (6 to 13 MHz) linear transducer and confirmation of placement by fluoroscopy at sites who do this in clinical practice. The subject will be prepped and draped and placed in supine position in a suite with continuous vital sign monitoring and advanced cardiac life support equipment and IV placement. Local anesthesia with 1% buffered lidocaine will be achieved. After visualization of Chassaignac's tubercle of C6 is identified along with the carotid artery, internal jugular vein and longus colli and capitus muscles, a 25-gauge echo-enhanced needle will be inserted to inject anesthetic over 2 minutes anterior to the prevertebral fascia at the ventral aspect of the longus colli muscle, medial to Chassaignac's tubercle. The needle will be withdrawn and the subject will be monitored for a minimum of 30 minutes.

PROCEDURE

Sham Stellate Ganglion Block

The Sham protocol is identical to the SGB protocol except "After needle tip confirmation and negative aspiration, normal saline (0.9%) + contrast (unlabeled to keep treater blinded) will be slowly injected over 2 minutes while closely monitoring the subject."

Sponsors & Collaborators

• Analydata, Inc.

  collaborator INDUSTRY

• VA Office of Research and Development

  lead FED

Principal Investigators

• Michael Hollifield, MD · VA Long Beach Healthcare System, Long Beach, CA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-17

Primary Completion

2025-09-30

Completion

2026-06-30

Countries

• United States

Study Locations