Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder

What this trial studies

Posttraumatic Stress Disorder (PTSD) is a trauma- and stress-related disorder arising from an experienced or witnessed traumatic event, most commonly actual or threatened death, serious injury, or sexual violence. There is a distinct pattern of intrusion and avoidance, as well as negative alterations in cognitions, mood, arousal, and reactivity, leading to serious impairments in personal, social and occupational functioning. The risk of PTSD is elevated in military and public safety personnel, and first responders. Despite advances in evidence-based treatments for PTSD, optimal outcomes are often not achieved, particularly in military veterans. One of the treatment-interfering factors is persistent hyperarousal (abnormally heightened state of anxiety and alertness), which prevents engagement in trauma processing and contributes to medication intolerance and substance misuse. The search for novel methods to target hyperarousal and underlying responses of the sympathetic nervous system have provided some promising pharmacologic approaches, such as the use of the adrenergic (adrenaline-related) blockers propranolol and prazosin. There is a need for novel and complementary approaches to normalize sympathetic (fight-or-flight) regulation in PTSD to provide symptom relief and facilitate its treatment and recovery. Stellate ganglion block (SGB) is a medical procedure that involves injection of local anesthetic around the stellate ganglion, which is a collection of sympathetic (figh…

Who can join: the full rules

Inclusion Criteria:

1. Diagnosis of PTSD according to DSM-5 criteria with prominent and persistent cluster E hyperarousal symptoms
2. Age 18-69 years
3. Under care of a mental health clinician
4. Not benefited from adequate trials of pharmacological or psychological evidence-based treatment and/or a preference and consent for a trial of SGB

Exclusion Criteria:

1. Assessed with high risk for suicide in the last 30 days (per patient's treating clinician at OSI clinic)
2. Diagnosis of bipolar or psychotic disorder
3. Moderate to severe substance use within the last 30 days (based on chart and verbal report from patient)
4. In process of disability assessment or legal action
5. Moderate or severe TBI (based on chart and verbal report from patient)
6. Pregnancy or breastfeeding
7. Current anticoagulant use (eligible if can be held before the procedure)
8. History of bleeding disorder (based on chart and verbal report from patient)
9. Infection, mass or anatomic abnormalities at target injection site
10. Myocardial infarction within 6 months of procedure (based on chart and verbal report from patient)
11. Pathologic bradycardia or irregularities of heart rate or rhythm (based on chart and verbal report from patient)
12. Symptomatic hypotension (BP\<90/60 + clinical symptoms of hypotension)
13. Phrenic or laryngeal nerve palsy (based on chart and verbal report from patient)
14. History of glaucoma (based on chart and verbal report from patient)
15. Uncontrolled seizure disorder (based on chart and verbal report from patient)
16. Known history of allergy to local anesthetics (based on chart and verbal report from patient)
17. Severe COPD (based on chart and verbal report from patient)
18. Pneumothorax (based on chart and verbal report from patient)
19. Contralateral pneumonectomy or non-functional lung (based on chart and verbal report from patient)
20. Active systemic infection (based on chart and verbal report from patient)
21. Patient refusal/inability to tolerate procedure/positioning
22. Contraindication to MR imaging
23. Any other condition that in the opinion of the investigator could create a hazard to the participant's safety, endanger the study procedures, or interfere with the interpretation of study results.

Where it's running

• The Royal Ottawa Mental Health Centre
  Ottawa, Ontario, Canada

Study contacts

• Principal investigator: Rebecca Gomez, MD — Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.