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

NCT ID: NCT01629537

Last Updated: 2017-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2016-04-30

Brief Summary

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.

Conditions

Post Traumatic Stress Disorder (PTSD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

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.

Group Type: OTHER

Placebo Procedure

Intervention Type: PROCEDURE

In participants randomized to the placebo injection, the same positioning, monitoring, sterile preparation and technique and local anesthesia protocol will be used. The 22 g needle will instead be placed in the subcutaneous, superficial tissues overlying the C6 tubercle, but superficial enough that the prevertebral fascial plane of the stellate ganglion will not be breached. Using fluoroscopic guidance, this needle will be injected with 2 cc of contrast dye to confirm superficial spread. The needle will then be injected with 5 cc of preservative free normal saline and the needle will be removed.

Stellate Ganglion Block (SGB)

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.

Group Type: EXPERIMENTAL

Stellate Ganglion Block injection with ropivicane

Intervention Type: PROCEDURE

For participants receiving the stellate ganglion injection with ropivicaine, a 22 g needle will be directed percutaneously to the anterolateral C6 vertebral body Using ultrasound guidance to avoid the nearby vascular structures and identify the appropriate vertebral level and tissue plane. After negative aspiration for blood and CSF, and digital subtraction, 2cc of Iohexol,(Omnipaque 180) will be injected through the needle under live fluoroscopy to visualize dye spread over the pre-vertebral plane At this point, 7 cc 0.5% ropivicaine will be injected and the needle will be removed.

Interventions

Stellate Ganglion Block injection with ropivicane

For participants receiving the stellate ganglion injection with ropivicaine, a 22 g needle will be directed percutaneously to the anterolateral C6 vertebral body Using ultrasound guidance to avoid the nearby vascular structures and identify the appropriate vertebral level and tissue plane. After negative aspiration for blood and CSF, and digital subtraction, 2cc of Iohexol,(Omnipaque 180) will be injected through the needle under live fluoroscopy to visualize dye spread over the pre-vertebral plane At this point, 7 cc 0.5% ropivicaine will be injected and the needle will be removed.

Intervention Type: PROCEDURE

Placebo Procedure

In participants randomized to the placebo injection, the same positioning, monitoring, sterile preparation and technique and local anesthesia protocol will be used. The 22 g needle will instead be placed in the subcutaneous, superficial tissues overlying the C6 tubercle, but superficial enough that the prevertebral fascial plane of the stellate ganglion will not be breached. Using fluoroscopic guidance, this needle will be injected with 2 cc of contrast dye to confirm superficial spread. The needle will then be injected with 5 cc of preservative free normal saline and the needle will be removed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

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

Sponsors

United States Naval Medical Center, San Diego

FED

Sponsor Role: lead

Responsible Party

Steven Hanling

Department of Psychaitry Research Director, Mental Health Directorate

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Steven Hanling, MD, CDR

Role: PRINCIPAL_INVESTIGATOR

United States Naval Medical Center, San Diego

Locations

United States Naval Medical Center San Diego

San Diego, California, United States

Countries

United States

Other Identifiers

NMCSD.2010.0157

Identifier Type: -

Identifier Source: org_study_id