Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors (SGB-PsychoED)

Columbia University

Status: Terminated

Conditions: PTSD; Anxiety and Fear; Health Behavior; Sleep Disturbance; Cardiac Arrest

Treatments: Procedure: Normal saline injection; Procedure: stellate ganglion block injection; Behavioral: Psychoeducation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04582396

5P30AG064198-02 (U.S. NIH Grant/Contract)

AAAS8305

Details and patient eligibility

About

This is a pilot randomized controlled trial (RCT) to gain preliminary evidence regarding the acceptability, tolerability, safety, and efficacy of a combined intervention of Stellate Ganglion Blockade (SGB) and psychoeducation on trauma symptoms and health behaviors in patients exhibiting early PTSD symptoms after cardiac arrest (CA).

Primary Aim 1 (Feasibility outcomes): Gain preliminary evidence regarding the acceptability, tolerability, and safety of conducting a randomized trial that evaluates a single SGB treatment in conjunction with psychoeducation among CA patients with early PTSD symptoms.

Secondary Aim 1 (Treatment-related outcomes): Test, whether SGB/psychoeducation treatment in CA patients with clinically significant PTSD symptoms is associated with reduced cardiac anxiety, PTSD symptoms, and improved health behaviors (physical activity and sleep duration), assessed objectively by a wrist-worn accelerometer for 4 weeks post-discharge.

Full description

Every year in the U.S., 500,000 people experience sudden cardiac arrest (CA), caused by electrical disturbances across cardiac tissue, leading to marked arrhythmia that ultimately results in the heart ceasing to pump blood to the brain, lungs, and other organs. Due to advances in bundled post-arrest care, cardio-cerebral resuscitation, and effective cooling protocols, a substantial proportion of patients who receive guideline-based care (nearly 1 in 3 for out-of-hospital and ~50% for in-hospital CA) now survive this once universally fatal condition. While most survivors retain their cognitive function and physical independence, many grapple with CA's psychological consequences in the context of learning that they were "clinically dead."

In particular, many describe the CA experience as traumatic, and up to 1 in 3 CA survivors subsequently develop posttraumatic stress disorder (PTSD). Not only is PTSD common in CA patients, but there is evidence that PTSD after CA may influence health behaviors and prognosis.

Treatment of early PTSD and cardiac anxiety symptoms after CA requires timely intervention. Recent studies show that SGB is a safe and acceptable intervention for reducing PTSD symptoms in combat veterans. SGB treatment has never been tested to treat PTSD induced by acute medical events such as CA.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria

1. Age 18 years or older
2. Fluent in English or Spanish
3. A diagnosis of cardiac arrest (CA)
4. Admitted to the New York-Presbyterian Hospital
5. Elevated symptoms of psychological distress a. PCL-5 > 32 with a minimum of 2 weeks after cardiac arrest

Exclusion criteria

1. A prior SGB treatment
2. Severe brain injury defined as Cerebral Performance Category Score ≥3, and/or significant aphasia, dysarthria, or cognitive impairment precluding ability to complete study questionnaires as determined by interviewer
3. Terminal non-cardiovascular illness (life expectancy <1 year)
4. Severe mental illness requiring urgent psychiatric hospitalization
5. Alcohol or substance abuse that would impede ability to complete study
6. Unavailable for telephone and in-person follow-up
7. Allergy to amide local anesthetics (e.g., ropivacaine, bupivacaine)
8. Pre-existing Horner's syndrome
9. Pregnancy
10. Current anticoagulant use
11. History of a bleeding disorder
12. Infection or mass at injection site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

Stellate Ganglion Block + Psychoeducation

Experimental group

Description:

For the active SGB arm, 7 to 8 mL of ropivacaine, 0.5%, will be injected around and into the site of the ganglion once before the hospital discharge. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.

Treatment:

Behavioral: Psychoeducation

Procedure: stellate ganglion block injection

Normal saline injection + Psychoeducation

Placebo Comparator group

Description:

For the sham procedure, 1 to 2 mL of preservative-free normal saline will be injected into deep musculature in the neck. They will also receive a 30 minutes session of psychoeducation by a health professional with experience working with CA patients.

Treatment:

Behavioral: Psychoeducation

Procedure: Normal saline injection