Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Royal's Institute of Mental Health Research
• Collaborator: Ottawa Hospital Research Institute
• Treatments: Bupivacaine

Criteria

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.