A Phase 2 interventional study of SGB Bupivacaine and SGB Bupivacaine + Ketamine in Posttraumatic Stress Disorder (PTSD), sponsored by The Royal's Institute of Mental Health Research. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years to 69 Years. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by The Royal's Institute of Mental Health Research · Phase 2, Interventional, and Treatment
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.
The most common treatment for Post-traumatic 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 thoroughly evaluated in Canada. More research is thereby needed to use SGB as a method of PTSD treatment in Canada, and to better understand how it works to reduce symptoms associated with this condition.
The use of the SGB procedure for PTSD has not yet been approved by Health Canada for the general population.
WHY IS THIS STUDY BEING DONE? The purpose of this study is to better understand how SGB works in helping reduce symptoms associated with PTSD, and to understand if infusing bupivacaine (the standard local anesthetic used for SGB) with ketamine increases the effectiveness of the procedure. Combining ketamine with local anaesthetics such as lidocaine or bupivacaine is a specialized approach used in interventional pain management. Research has shown that this combination works safely in providing powerful relief for severe treatment resistant chronic conditions. However, combining ketamine in the context of an SGB injection, or as a supporting treatment for PTSD symptoms, has yet to be studied.
To do this, the study will have two Parts. The first Part is the Randomized Controlled Trial (RCT), and the second Part is the study extension. In Part I, participants will be randomized into groups where they will either receive one SGB injection of bupivacaine alone, one injection of bupivacaine combined with ketamine, or no injection. We will also be collecting additional information through the use of pupillometry (a non-invasive technique that measures the size and reactivity of your pupil) to monitor the effectiveness of each individual procedure. Additionally, during this project we hope to obtain feedback from both the participant and their family/support network about their experience and satisfaction with the SGB procedure and its effects. This will help us understand for whom SGB works best and will provide us with information and experience for introducing SGB into programs within The Royal. A series of questionnaires will also be asked to understand more about each participant.
In Part II, all participants who meet eligibility criteria, including those who received no injection during Part I, will have the option to finish and exit the study, or continue and receive one standard SGB injection (bupivacaine) during the extension. This means those who received an injection during the RCT will have the option for a second injection, and those who were randomized to the Control Group will have the option to receive one injection.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 126 is above the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →The Royal's Institute of Mental Health Research is the lead sponsor of 7 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: SGB Bupivacaine
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.
Combination Product: SGB Bupivacaine + Ketamine
Participants selected to this group will not receive any intervention and continue with their treatments as usual.
6 mL of 0.5% preservative-free bupivacaine plus 2 mL normal saline
6 mL of 0.5% preservative-free bupivacaine plus 2 mL ketamine (10 mg/mL)
Also known as: Group 2: One SGB injection combining standard local anesthetic, bupivacaine, with Ketamine
Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score
The mean difference in the change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score, specifically evaluated by comparing the Bupivacaine + Ketamine group to the Bupivacaine alone group.
Time frame: From baseline to +4 weeks
Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score
The mean difference in the change of the CAPS-5 total symptom severity score , specifically evaluated by comparing the Bupivacaine + Ketamine group to the Control group.
Time frame: From baseline to +4 weeks
The mean change in PTSD Check List-5 (PCL-5) scores
The mean change in PCL-5 scores between the Bupivacaine + Ketamine group and the Bupivacaine alone group.
Time frame: From baseline to +4 weeks
The mean change in PCL-5 scores
The mean change in PCL-5 scores between the Bupivacaine + Ketamine group versus the Control group.
Time frame: From baseline to +4 weeks
Proportion of patients achieving reliable change (at least 14-point reduction) in the total score on Outcome Questionnaire 45 (OQ45)
Proportion of patients achieving reliable change (at least 14-point reduction) in the total score on OQ45.2 reflecting improvement in symptom burden and functioning
Time frame: from baseline to +4, +8 and +12 weeks.
Changes in participant's symptomatology and overall functioning from the perspective of the participant's family and support network measured by the FAST-Q
Changes in participant's symptomatology and overall functioning from the perspective of the participant's family and support network measured by the FAST-Q
Time frame: From baseline to +4 and +12 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Feb 2027; primary completion for Feb 2029, 24 months later.
Of 87 non-industry phase 2 interventional studies under Stress Disorders, Post-Traumatic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 59. This study's planned 24 months is below that.
Counting every sponsor, half of 118 studies reached it within 38 months; a quarter within 23 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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Stress Disorders, Post-Traumatic →
The Royal's Institute of Mental Health Research