Stellate Ganglion Blockade to Reduce Cardiac Anxiety and PTSD Symptoms in Cardiac Arrest Survivors

NCT ID: NCT04582396

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-11
• Study Completion Date: 2021-04-19

Brief Summary

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.

Detailed 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Stellate Ganglion Block + Psychoeducation

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.

Group Type: EXPERIMENTAL

stellate ganglion block injection

Intervention Type: PROCEDURE

A stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.

Psychoeducation

Intervention Type: BEHAVIORAL

The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior.

Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA

Normal saline injection + Psychoeducation

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.

Group Type: PLACEBO_COMPARATOR

Normal saline injection

Intervention Type: PROCEDURE

An injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.

Psychoeducation

Intervention Type: BEHAVIORAL

The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior.

Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA

Interventions

stellate ganglion block injection

A stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.

Intervention Type: PROCEDURE

Normal saline injection

An injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.

Intervention Type: PROCEDURE

Psychoeducation

The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior.

Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA

Intervention Type: BEHAVIORAL

Other Intervention Names

SGB injection; Sham procedure

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Sachin Agarwal

Assistant Professor of Neurology, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sachin Agarwal, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Columbia University/New York Presbyterian

Ian M Kronish, MD, MPH

Role: STUDY_DIRECTOR

Columbia University

Locations

Columbia University Medical Center/New York Presbyterian

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5P30AG064198-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

AAAS8305

Identifier Type: -

Identifier Source: org_study_id