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Not yet recruitingPhase 2

Enhancing the Effect of Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder: A Double-blind Randomized Controlled Trial of Bupivacaine vs Bupivacaine + Ketamine

NCT07927036 · The Royal's Institute of Mental Health Research

Closed to entry
Status
Not accepting participants
Phase 2
Phase
126
Target enrolment
1
Study sites
Outside the US

What it is testing

Summary

The goal of this clinical trial is to learn whether stellate ganglion block (SGB), with or without ketamine, can reduce symptoms of post-traumatic stress disorder (PTSD) in adults receiving care through the Operational Stress Injury (OSI) Clinic and military community partners. The main questions it aims to answer are: Does adding ketamine to the standard SGB anesthetic (bupivacaine) improve treatment effectiveness compared with bupivacaine alone? Does SGB reduce PTSD symptom severity compared with no injection (control group)? Researchers will compare participants receiving SGB with bupivacaine, SGB with bupivacaine plus ketamine, and no injection (control) to determine whether SGB reduces PTSD symptoms and whether ketamine enhances the effects of the procedure. Participants will: Be randomly assigned to receive SGB with bupivacaine, SGB with bupivacaine plus ketamine, or no injection during the randomized controlled trial portion of the study. Complete questionnaires and clinical interviews assessing PTSD symptoms, anxiety, depression, functioning, and quality of life. Participate in follow-up interviews to discuss their experiences with the treatment. Invite a family member or support person to complete a questionnaire about observed changes in symptoms and functioning. Have the option to receive a standard SGB procedure during the study extension phase, if eligible. This study will enroll approximately 126 participants and aims to improve understanding of how SGB works for PTSD and whether ketamine can enhance its therapeutic effects.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score

    Measured over From baseline to +4 weeks

  • Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score

    Measured over From baseline to +4 weeks

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 69 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: 1. DSM-5 diagnosis of PTSD of at least moderate severity confirmed by PCL-5 score ≥33 or CAPS-5 score ≥26 at screening visit 2. Age 18-69 years 3. Under care of a mental health clinician 4. Has not benefited from pharmacological and/or psychological evidence-based treatments for PTSD Exclusion Criteria: 1. Assessed with high risk for suicide in the last 30 days 2. Active mania/ hypomania or psychosis within the last 30 days 3. Moderate to severe substance use within the last 30 days 4. In process of disability assessment or legal action 5. Current participation in another treatment study for PTSD 6. Pregnancy or breastfeeding confirmed by urine test 7. Current anticoagulant use (eligible if can be held before the procedure) 8. History of bleeding disorder 9. Infection, mass or anatomic abnormalities at target injection site 10. Myocardial infarction within 6 months of procedure 11. Pathologic bradycardia or irregularities of heart rate or rhythm; 12. Symptomatic hypotension 13. Phrenic or laryngeal nerve palsy 14. History of glaucoma 15. Uncontrolled seizure disorder 16. History of allergy to local anesthetics 17. History of allergy to general anesthetics 18. Severe chronic obstructive pulmonary disease (COPD) 19. Current or reoccurring Pneumothorax 20. Contralateral pneumonectomy or non-functional lung 21. Active systemic infection 22. Bilateral procedure is always contraindicated due to risk of laryngeal/phrenic nerve dysfunction 23. Participant refusal/inability to tolerate procedure/positioning 24. End stage renal disease 25. Known allergy to Ketamine 26. Unable to hold stimulant or benzodiazepine medication prior to SGB procedure

Where

1 study site

FacilityCityRegionCountry
The RoyalOttawaOntarioCanada

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record. The registry also holds the most current version of everything above.

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NCT07927036 on ClinicalTrials.gov →

Last updated in the registry 2026-11-09. Registry records change; this page reflects the data build of 2026-11-10.

Related

Where this trial sits