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A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of POST TRAUMATIC STRESS DISORDER

18 Years
Open (Enrolling)
Post Traumatic Stress Disorder (PTSD)

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Trial Information

A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of POST TRAUMATIC STRESS DISORDER

Inclusion Criteria

1. Gender: Male and Female

2. Minimum Age/ Maximum Age: Over the age of 18

3. Accepts Healthy Volunteers:

Yes, but must be experiencing mild to severe symptoms of PTSD

Inclusion Criteria will include subjects who:

- Subjects, (male and/or female), experiencing moderate-to-severe PTSD Symptoms

- Subjects, (male and/or female), who elect to undergo the SGB procedure.

Exclusion Criteria will include subjects who:

- Have an acute, unstable medical condition i.e., temperature, blood pressure, heart
rate outside normal limits; electrolyte abnormalities; mental conditions which
preclude informed consent/unable to make decisions independently; on antibiotic
therapy; uncontrolled seizures; nausea/vomiting; night sweats; blood dyscrasias.

- Have acute infections or cardiac compromise or irregularities of heart rate or

- Pathlogic bradycardia

- Have local infections of the anterior neck region

- Have severe pulmonary disease, (in severe pulmonary disease, the patient may
experience severe shortness of breath on minimal exertion [even at rest], require
supplemental oxygen, is progressively disabled and may have a constant cough and
associated wheeze).

- Are anticoagulated

- Have a blood clotting disorder

- Have an American Society of Anesthesiologists (ASA) physical status score of 3 or
higher (severe systemic disease, not incapacitating)

- Have allergic reactions to local anesthetics and / or contrast dyes,

- Have conditions or disorders that affect cognitive functioning, including stroke,
past or present diagnosis of psychosis,

- Have conditions that invalidate testing procedures (e.g., English not first language,
inability to write, speak, read, etc.)

- Have Horner's syndrome on the right side

- Have a diagnosis of glaucoma

- Are pregnant

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Clinician Administered PSTD Scale (CAPS)

Outcome Description:

The CAPS is generally considered the gold standard for PTSD assessment, and will be used to determine severity of PTSD symptoms compared to the 1 week pre baseline measures at enrollment

Outcome Time Frame:

1 week

Safety Issue:


Principal Investigator

Anita Hickey, MD, CAPT

Investigator Role:

Principal Investigator

Investigator Affiliation:

United States Naval Medical Center, San Diego


United States: Federal Government

Study ID:




Start Date:

June 2011

Completion Date:

September 2012

Related Keywords:

  • Post Traumatic Stress Disorder (PTSD)
  • Post Traumatic Stress Disorder
  • Ganglion Cysts
  • Stress Disorders, Post-Traumatic
  • Stress Disorders, Traumatic



United States Naval Medical Center San Diego San Diego, California  92134-1005