Posttraumatic Stress Disorder (PTSD)Phase 2NCT07927036
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
A Phase 2 study testing SGB Bupivacaine and SGB Bupivacaine + Ketamine in people with Posttraumatic Stress Disorder (PTSD), run by The Royal's Institute of Mental Health Research at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Posttraumatic Stress Disorder (PTSD)
- What is being tested?
- SGB Bupivacaine and SGB Bupivacaine + Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteCanada
- Study dates
- 1 Feb 2027to 1 Feb 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-5 diagnosis of PTSD of at least moderate severity confirmed by PCL-5 score ≥33 or CAPS-5 score ≥26 at screening visit
- Age 18-69 years
- Under care of a mental health clinician
- Has not benefited from pharmacological and/or psychological evidence-based treatments for PTSD
Who cannot join
- Assessed with high risk for suicide in the last 30 days
- Active mania/ hypomania or psychosis within the last 30 days
- Moderate to severe substance use within the last 30 days
- In process of disability assessment or legal action
- Current participation in another treatment study for PTSD
- Pregnancy or breastfeeding confirmed by urine test
Show all 26Show fewer
- Current anticoagulant use (eligible if can be held before the procedure)
- History of bleeding disorder
- Infection, mass or anatomic abnormalities at target injection site
- Myocardial infarction within 6 months of procedure
- Pathologic bradycardia or irregularities of heart rate or rhythm;
- Symptomatic hypotension
- Phrenic or laryngeal nerve palsy
- History of glaucoma
- Uncontrolled seizure disorder
- History of allergy to local anesthetics
- History of allergy to general anesthetics
- Severe chronic obstructive pulmonary disease (COPD)
- Current or reoccurring Pneumothorax
- Contralateral pneumonectomy or non-functional lung
- Active systemic infection
- Bilateral procedure is always contraindicated due to risk of laryngeal/phrenic nerve dysfunction
- Participant refusal/inability to tolerate procedure/positioning
- End stage renal disease
- Known allergy to Ketamine
- Unable to hold stimulant or benzodiazepine medication prior to SGB procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
The Royal
Ottawa, Ontario, K1Z 7K4
Tammy Beaudoin, Director, Clinical Research, 613-722-6521 ext. 6214, tbeaudoin@theroyal.ca
About this study
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?
Read more
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.
Read the detailed description
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.
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Being tested
- SGB Bupivacaine, SGB Bupivacaine + Ketamine
- Keywords
- stellate ganglion block, posttraumatic stress disorder, bupivacaine, ketamine, treatment
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SGB BupivacaineDrug
6 mL of 0.5% preservative-free bupivacaine plus 2 mL normal saline
SGB Bupivacaine + KetamineCombination product
Also called Group 2: One SGB injection combining standard local anesthetic, bupivacaine, with Ketamine
6 mL of 0.5% preservative-free bupivacaine plus 2 mL ketamine (10 mg/mL)
| Study group | Role | What they receive |
|---|---|---|
| Group 1: One SGB injection with standard local anesthetic, bupivacaine | Active comparator | 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. Receives: Drug: SGB Bupivacaine |
| Group 2: One SGB injection combining standard local anesthetic, bupivacaine, with Ketamine | Experimental | 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. Receives: Combination Product: SGB Bupivacaine + Ketamine |
| Group 3: Treatment as usual | No intervention | Participants selected to this group will not receive any intervention and continue with their treatments as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From baseline to +4 weeks
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: From baseline to +4 and +12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study start1 Feb 2027 (estimated)
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress Disorder (PTSD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A three-arm randomized controlled parallel-group trial with a control and extension phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal's Institute of Mental Health Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Gomez, MD, The Royal's Institute of Mental Health Research
- Investigators
- Rebecca J Gomez, MD, Principal investigator, Research Institute (IMHR) at The Royal, Ottawa campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07927036
- Sponsor's protocol ID
- 300167
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07927036
- Acronym / sponsor ID
- 300167
- Conditions
- Posttraumatic Stress Disorder (PTSD)
- Keywords
- stellate ganglion block, posttraumatic stress disorder, bupivacaine, ketamine, treatment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- The Royal's Institute of Mental Health ResearchUniversity, hospital or other
- Study start
- 1 Feb 2027 (estimated)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 9 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A three-arm randomized controlled parallel-group trial with a control and extension phase.
| Arm | Type | Receives |
|---|---|---|
| Group 1: One SGB injection with standard local anesthetic, bupivacaine | Active comparator | Drug: SGB BupivacaineOne 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. |
| Group 2: One SGB injection combining standard local anesthetic, bupivacaine, with Ketamine | Experimental | Combination Product: SGB Bupivacaine + KetamineThe 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. |
| Group 3: Treatment as usual | No intervention | –Participants selected to this group will not receive any intervention and continue with their treatments as usual. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-5 diagnosis of PTSD of at least moderate severity confirmed by PCL-5 score ≥33 or CAPS-5 score ≥26 at screening visit
- Age 18-69 years
- Under care of a mental health clinician
- Has not benefited from pharmacological and/or psychological evidence-based treatments for PTSD
Key exclusion criteria (26 listed)
- Assessed with high risk for suicide in the last 30 days
- Active mania/ hypomania or psychosis within the last 30 days
- Moderate to severe substance use within the last 30 days
- In process of disability assessment or legal action
- Current participation in another treatment study for PTSD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SGB Bupivacaine6 mL of 0.5% preservative-free bupivacaine plus 2 mL normal saline | Drug | Group 1: One SGB injection with standard local anesthetic, bupivacaine |
| SGB Bupivacaine + KetamineAlso: Group 2: One SGB injection combining standard local anesthetic, bupivacaine, with Ketamine6 mL of 0.5% preservative-free bupivacaine plus 2 mL ketamine (10 mg/mL) | Combination product | Group 2: One SGB injection combining standard local anesthetic, bupivacaine, with Ketamine |
Primary outcome
Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score
Time frame: From baseline to +4 weeks
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.
Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score
Time frame: From baseline to +4 weeks
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.
4 secondary outcomes
The mean change in PTSD Check List-5 (PCL-5) scores
Time frame: From baseline to +4 weeks
The mean change in PCL-5 scores
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)
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
Time frame: From baseline to +4 and +12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rebecca J Gomez, MD principal investigator
Research Institute (IMHR) at The Royal, Ottawa campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SGB Bupivacaine and SGB Bupivacaine + Ketamine in people with Posttraumatic Stress Disorder (PTSD), run by The Royal's Institute of Mental Health Research at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca J Gomez, MD (6137226521, regomez@theroyal.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total symptom severity score (time frame: From baseline to +4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2026.