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ENROLLING BY INVITATION

NCT05427500

PHASE3

Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder

Sponsor: The Royal's Institute of Mental Health Research

View on ClinicalTrials.gov

Summary

The most common treatment for Posttraumatic Stress Disorder (PTSD) is trauma-focused therapy and/or prescription of medication(s). However, these treatments may not directly reduce symptoms associated with PTSD, making it difficult for patients to be treated for this condition and recover. Stellate ganglion block (SGB) is a medical procedure that involves injection of a local anesthetic (a medication that causes reduced sensation/feeling in a given area) around the stellate ganglion, which is a collection of nerves near the base of the neck. This procedure causes a short-lived, temporary shutdown of nerve signals (up to 5-7 hours) and is commonly performed in Canada for certain pain and medical conditions. In the last decade, several studies, including those involving members of military groups, have shown that SGB can result in a rapid and sustained drop in symptoms related to PTSD such as overwhelming anxiety, increased irritability, heightened alertness, and exaggerated startle. Considering these results and the known safety of this procedure (as demonstrated by previous research and use in other illnesses), SGB has been increasingly used to treat PTSD among veterans in the United States but has not yet been evaluated in Canada. More research is thereby needed to use SBG as a method of PTSD treatment in Canada, and to better understand how it works to reduce symptoms associated with this condition. Health Canada, the organization which oversees clinical trials such as this one, has not approved the use of the SGB procedure for PTSD in the general population, however Health Canada has allowed the use of SGB in this study to better understand how it works and how it may be used in the future to treat PTSD-related symptoms in those who feel that common treatments are not effective.

Official title: Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder: Outcome Evaluation, Mechanism of Action, and Integration in Care - A Phase III Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 69 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-03-30

Completion Date

2027-01-30

Last Updated

2025-07-25

Healthy Volunteers

Conditions

PTSD

Interventions

DRUG

5 mL of 0.5% preservative-free bupivacaine

IV will be inserted. Patient will be connected to cardiorespiratory monitors. The neck will be cleansed twice. A high frequency (15-6 MHz) linear ultrasound probe will be used to identify the arteries, jugular vein, and other important vasculature. Once a clear path for the needle is identified, the skin is anesthetized. A cutting tip spinal needle is then inserted at the lateral aspect of the field and advanced in-plane under ultrasound visualization. A test injection is injected to verify placement, then 5 mL of 0.5% preservative-free bupivacaine will be injected. Per standard SGB procedure, vitals will be measured post-SGB and participants will remain in the clinic for approximately 15 minutes to monitor for any serious adverse events.

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.

Locations (1)

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, Canada