A Randomized, Placebo-Controlled Trial of Stellate Ganglion Block in the Treatment of Post Traumatic Stress Disorder

Naval Medical Center

Status and phase: Completed; Phase 2

Conditions: Post Traumatic Stress Disorder (PTSD)

Treatments: Procedure: Stellate Ganglion Block injection with ropivicane; Procedure: Placebo Procedure

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01629537

NMCSD.2010.0157

Details and patient eligibility

About

Post Traumatic Stress Disorder (PTSD), is a devastating condition which causes distress or impairment in social, occupational or other important aspects of functioning. The occurrence of PTSD in the military is on the rise. This has significantly impacted military members, their families, and society as a whole. According to an expert panel convened by the Institute of Medicine in 2007, the effectiveness of most currently employed PTSD therapies is low. Safe and effective treatments are urgently needed. The specific aim of this investigation is to evaluate the effectiveness of a novel approach to relieve PTSD symptoms, utilizing a procedure commonly used in pain management, a Stellate Ganglion Block (SGB) with local anesthesia. Male soldiers experiencing moderate to severe symptoms of PTSD will be recruited for evaluation of Stellate Ganglion Block with local anesthesia as an intervention for PTSD treatment. Participants will be randomized to receive either the SGB with local anesthesia to C6 tubercle or a sham procedure involving a subcutaneous saline injection to the neck. The PTSD symptoms before and after the procedure will be measured using a comprehensive clinician-administered scale, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures. Subjects will undergo assessment prior to the procedure, one week following the procedure, one month and 3 months following the procedure. Patients receiving sham injections will be allowed to cross over to the treatment group. Based on published case reports of Lipov et al in Chicago and Mulvaney et al from Walter Reed Medical Center, who utilized this technique to successfully treat soldiers with combat-related PTSD, we predict that the use of Stellate Ganglion Block will result in reduction of PTSD symptoms as measured by clinician-administered scales, self-report measures, objective measures of cognitive ability, and physiologic reactivity measures, leading to a significant and lasting reduction of PTSD symptoms.

Enrollment: 41 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.
• DEERS Eligible

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 rhythm.
• Pathologic 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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41 participants in 2 patient groups

Placebo

Other group

Description:

Subjects 1 month post in the placebo group who demonstrate either the same level of PTSD severity at enrollment or worsening of the condition (i.e., CAPS score greater than or equal to 40) will be offered SGB treatment and crossed over to active treatment. Patients who cross over from placebo to active SGB treatment will be followed one week, one month and three months after cross over.

Treatment:

Procedure: Placebo Procedure

Stellate Ganglion Block (SGB)

Experimental group

Description:

Subjects assigned to SGB arm will undergo SGB procedure and be followed one week, one month and three months after procedure or until CAPS score is below 40.

Treatment:

Procedure: Stellate Ganglion Block injection with ropivicane