SGB + Ketamine for Post-Traumatic Stress Disorder
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Rebecca J Gomez, MD
Principal Investigator
Research Institute (IMHR) at The Royal, Ottawa campus
Are You a Good Fit for This Trial?
This trial is for adults with post-traumatic stress disorder (PTSD) who are receiving care through the OSI Clinic or military community partners. Participants must be able to complete interviews and questionnaires about their symptoms and daily life.Inclusion Criteria
Exclusion Criteria
What Are the Treatments Tested in This Trial?
Interventions
- SGB Bupivacaine
- SGB Bupivacaine + Ketamine
Trial Overview
The study compares three groups: one gets a nerve block injection (SGB) with bupivacaine, another gets SGB with bupivacaine plus ketamine, and a third group receives no injection. The goal is to see if adding ketamine improves PTSD treatment results.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
The bupivacaine dose administered to Group 2 is identical to that administered to Group 1, with the addition of 20 mg ketamine (2 mL of a 10 mg/mL solution). A fixed ketamine dose of 20 mg was selected to approximate a low-dose (subanesthetic) exposure of 0.3 mg/kg in a 70 kg adult (21 mg), while allowing standardized dosing across participants. This dose was chosen to remain within a range commonly used in clinical research investigating the analgesic and neuropsychiatric effects of ketamine. This is the accepted standard and widely used dose in clinical practice.
One dose of 6mL 0.5% bupivacaine combined with 2ml normal saline. The dose and medication provided to Group 1 is in line with current research practice for SGB which suggests a dosage between 6mL and 9 mL of local anaesthetic. Saline is included in the injection to match the volume of the injection for Group 2 without adding additional medical properties to the solution.
Participants selected to this group will not receive any intervention and continue with their treatments as usual.
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Who Is Running the Clinical Trial?
The Royal's Institute of Mental Health Research
Lead Sponsor
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