PTSDPhase 3NCT05427500
Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder
A Phase 3 study testing 5 mL of 0.5% preservative-free bupivacaine in people with PTSD, run by The Royal's Institute of Mental Health Research at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- PTSD
- What is being tested?
- 5 mL of 0.5% preservative-free bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteCanada
- Study dates
- 30 Mar 2024to 30 Jan 2027
- Phase
- Phase 3
- 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
- Diagnosis of PTSD according to DSM-5 criteria with prominent and persistent cluster E hyperarousal symptoms
- Age 18-69 years
- Under care of a mental health clinician
- Not benefited from adequate trials of pharmacological or psychological evidence-based treatment and/or a preference and consent for a trial of SGB
Who cannot join
- Assessed with high risk for suicide in the last 30 days (per patient's treating clinician at OSI clinic)
- Diagnosis of bipolar or psychotic disorder
- Moderate to severe substance use within the last 30 days (based on chart and verbal report from patient)
- In process of disability assessment or legal action
- Moderate or severe TBI (based on chart and verbal report from patient)
- Pregnancy or breastfeeding
Show all 23Show fewer
- Current anticoagulant use (eligible if can be held before the procedure)
- History of bleeding disorder (based on chart and verbal report from patient)
- Infection, mass or anatomic abnormalities at target injection site
- Myocardial infarction within 6 months of procedure (based on chart and verbal report from patient)
- Pathologic bradycardia or irregularities of heart rate or rhythm (based on chart and verbal report from patient)
- Symptomatic hypotension (BP<90/60 + clinical symptoms of hypotension)
- Phrenic or laryngeal nerve palsy (based on chart and verbal report from patient)
- History of glaucoma (based on chart and verbal report from patient)
- Uncontrolled seizure disorder (based on chart and verbal report from patient)
- Known history of allergy to local anesthetics (based on chart and verbal report from patient)
- Severe COPD (based on chart and verbal report from patient)
- Pneumothorax (based on chart and verbal report from patient)
- Contralateral pneumonectomy or non-functional lung (based on chart and verbal report from patient)
- Active systemic infection (based on chart and verbal report from patient)
- Patient refusal/inability to tolerate procedure/positioning
- Contraindication to MR imaging
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder: Outcome Evaluation, Mechanism of Action, and Integration in Care - A Phase III Randomized Controlled Trial
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.
Read the detailed description
Posttraumatic Stress Disorder (PTSD) is a trauma- and stress-related disorder arising from an experienced or witnessed traumatic event, most commonly actual or threatened death, serious injury, or sexual violence. There is a distinct pattern of intrusion and avoidance, as well as negative alterations in cognitions, mood, arousal, and reactivity, leading to serious impairments in personal, social and occupational functioning. The risk of PTSD is elevated in military and public safety personnel, and first responders. Despite advances in evidence-based treatments for PTSD, optimal outcomes are often not achieved, particularly in military veterans. One of the treatment-interfering factors is persistent hyperarousal (abnormally heightened state of anxiety and alertness), which prevents engagement in trauma processing and contributes to medication intolerance and substance misuse. The search for novel methods to target hyperarousal and underlying responses of the sympathetic nervous system have provided some promising pharmacologic approaches, such as the use of the adrenergic (adrenaline-related) blockers propranolol and prazosin. There is a need for novel and complementary approaches to normalize sympathetic (fight-or-flight) regulation in PTSD to provide symptom relief and facilitate its treatment and recovery.
Stellate ganglion block (SGB) is a medical procedure that involves injection of local anesthetic around the stellate ganglion, which is a collection of sympathetic (fight-or-flight) nerves near the base of the neck (C6-7). This procedure causes a short-lived shutdown of sympathetic nerve signals (up to 5-7 hours) and is commonly performed in Canada for certain pain and medical conditions. SGB is an interventional procedure that temporarily blocks sympathetic signaling to the arms, neck and head with long-established therapeutic benefits for sympathetically maintained pain and other medical conditions. In the past decade, SGB was found to provide a rapid and sustained reduction of PTSD symptoms in numerous case reports and series. Further, two randomized controlled trials of SGB in PTSD have been conducted. The first study in active and retired military personnel with combat and non-combat PTSD did not differentiate the effect of SGB from sham control one week or one month post-injection , although these results were inconclusive due to methodological limitations. The second study in active-duty military personnel established substantial efficacy of SGB that was administered twice in a 2-week interval when assessed at eight weeks after the first injection . Notably, most of the studies above were conducted in predominantly male active-duty military samples and none specifically in veterans, law enforcement officers, or first responders. Considering these results and the known safety of this procedure, SGB has been increasingly used to treat PTSD in the United States Veterans Affairs (VA) system, but has not yet been evaluated in Canada.
The mechanism of action of SGB in PTSD is not well understood. Presumably, SGB directly reduces peripheral sympathetic tone but may also project to the central nervous system to activate neuroplasticity processes. The current consensus is that SGB has a unique adjunct potential in PTSD treatment, but the parameters of its use and mechanism of action require further study. In order to enhance care and in response to requests from our patients and their clinicians, we initiated a collaboration between the OSI and TOH Pain clinics to facilitate access to SGB for our patients, particularly those who are not improving with traditional therapies because of intractable hyperarousal and anxiety. To date, 15 patients have undergone off-label SGB procedures at The Ottawa Hospital (TOH) Pain Clinic, seven for whom we have clinical data up to eight weeks post-SGB. We are still collecting follow-up data for the other eight patients, who had the procedure done more recently. Of those seven who underwent SGB procedures prior to October 2021, five were responders on the PTSD Checklist for DSM-5 (PCL-5), as evidenced by a 10-point decrease in the total score, between one week pre-SGB and eight weeks post-SGB. Mean Quick Inventory of Depressive Symptomatology (QIDS-SR) scores decreased from the severe to moderate range. Within 2 weeks of the procedure, one patient commented that he had "less anxiety, no panic attacks," and another reported, "It was like the entire planet felt less menacing and I felt calmer than I had in years." There were no serious adverse events related to the SGB procedure. In summary, current treatments for PTSD have shortcomings and less success in military veterans. One of the most significant challenges for recovery from PTSD is an overactive "fight-or-flight" state, fueled by the sympathetic nervous system. Patients struggle with near constant hyperarousal as they are in a state of physical and mental readiness to react to a threat. While this reaction is appropriate in dangerous situations, as a symptom of PTSD, it becomes excessive and uncontrollable, leading to persistent anxiety, irritability, agitation, startle, and sleep problems as well as triggering traumatic memories and standing in the way of regular life activities. Currently, even the best treatments for PTSD do not directly reduce hyperarousal or sympathetic activity, making it more difficult for patients to engage in and benefit from trauma-focused therapy or medications. Sufferers are often prompted to self-medicate with alcohol and other substances, which also negatively impact the patient's family and support network. This significant treatment gap calls for exploring novel ways to lessen the entrenched "fight or flight" state in those with PTSD.
- Conditions
- PTSD
- Being tested
- 5 mL of 0.5% preservative-free bupivacaine
- Keywords
- Stellate Gangllion Block, Canadian Armed Forces, Veterans, Royal Canadian Mounted Police
- 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.
5 mL of 0.5% preservative-free bupivacaineDrug
Also called SteriMax Bupivicaine
IV will be inserted. Patient will be connected to cardiorespiratory monitors. The neck will be cleansed twice. A high frequency (15-6 MHz) linear ultrasound probe will be used to identify the arteries, jugular vein, and other important vasculature. Once a clear path for the needle is identified, the skin is anesthetized. A cutting tip spinal needle is then inserted at the lateral aspect of the field and advanced in-plane under ultrasound visualization. A test injection is injected to verify placement, then 5 mL of 0.5% preservative-free bupivacaine will be injected. Per standard SGB procedure, vitals will be measured post-SGB and participants will remain in the clinic for approximately 15 minutes to monitor for any serious adverse events.
| Study group | Role | What they receive |
|---|---|---|
| Single SGB | Other | This arm will receive a single 5 mL dose of 0.5% preservative-free bupivacaine. Receives: Drug: 5 mL of 0.5% preservative-free bupivacaine |
| Repeated SGB | Other | This arm will receive two 5 mL doses of 0.5% preservative-free bupivacaine. Receives: Drug: 5 mL of 0.5% preservative-free bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring patient response and remission of PTSD symptoms
Proportion of patients showing response (at least 10-point reduction) and remission (total score < 33) in symptoms of PTSD on PCL-5
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Monitoring patient improvement on Clinician Administered PTDS Scale for DSM-5 (CAPS-5)
Proportion of patients showing response (at least 10-points reduction) and loss of diagnosis on CAPS-5
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Monitoring patient improvement in symptom burden and functioning
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 pre-SGB to final study visit 12-weeks post procedure.
Secondary outcomes (6)
Changes from baseline in hypervigilance
Measured by the Brief Hypervigilance Scale
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Changes from baseline in anxiety
Measured by the Overall Anxiety Severity Impairment Scale
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Changes from baseline in depression
Measured by the Quick Inventory of Depressive Symptomatology
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Changes from baseline in pain scale scores
Measured by the Brief Pain Inventory
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Ratings of participant satisfaction and recommendations for future use of SGB
Measured by qualitative self report scale
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Changes in participant's symptomatology and overall functioning from the perspective of the participant's family and support network
Measured by Family And Support Team-Questionnaire
Measured: From pre-SGB to final study visit 12-weeks post procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start30 Mar 2024
- Primary completion30 Jan 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for PTSDStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal's Institute of Mental Health Research
- Sponsor type
- University, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Responsible party
- Principal investigator, Rebecca Gomez, MD, The Royal's Institute of Mental Health Research
- Investigators
- Rebecca Gomez, MD, Principal investigator, Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05427500
- Sponsor's protocol ID
- 2022001
- Status last verified
- Jul 2025
- First submitted
- 9 Jun 2022
- Last updated
- 25 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American Psychiatric Association, DSM-5 Task Force. (2013). Diagnostic and Statistical Manual of Mental Disorders: DSM-5™ (5th ed.). American Psychiatric Publishing, Inc
Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
PubMed 26241600Krystal JH, Davis LL, Neylan TC, A Raskind M, Schnurr PP, Stein MB, Vessicchio J, Shiner B, Gleason TC, Huang GD. It Is Time to Address the Crisis in the Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement of the PTSD Psychopharmacology Working Group. Biol Psychiatry. 2017 Oct 1;82(7):e51-e59. doi: 10.1016/j.biopsych.2017.03.007. Epub 2017 Mar 14. No abstract available.
PubMed 28454621Hoge CW. Interventions for war-related posttraumatic stress disorder: meeting veterans where they are. JAMA. 2011 Aug 3;306(5):549-51. doi: 10.1001/jama.2011.1096. No abstract available.
PubMed 21813436DePierro J, Lepow L, Feder A, Yehuda R. Translating Molecular and Neuroendocrine Findings in Posttraumatic Stress Disorder and Resilience to Novel Therapies. Biol Psychiatry. 2019 Sep 15;86(6):454-463. doi: 10.1016/j.biopsych.2019.07.009. Epub 2019 Jul 24.
PubMed 31466562Aleanakian R, Chung BY, Feldmann RE Jr, Benrath J. Effectiveness, Safety, and Predictive Potential in Ultrasound-Guided Stellate Ganglion Blockades for the Treatment of Sympathetically Maintained Pain. Pain Pract. 2020 Jul;20(6):626-638. doi: 10.1111/papr.12892. Epub 2020 May 17.
PubMed 32255250Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available.
PubMed 19034755Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151.
PubMed 25269132Lipov E, Ritchie EC. A review of the use of stellate ganglion block in the treatment of PTSD. Curr Psychiatry Rep. 2015 Aug;17(8):599. doi: 10.1007/s11920-015-0599-4.
PubMed 26073361Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402.
PubMed 27187898Rae Olmsted KL, Bartoszek M, Mulvaney S, McLean B, Turabi A, Young R, Kim E, Vandermaas-Peeler R, Morgan JK, Constantinescu O, Kane S, Nguyen C, Hirsch S, Munoz B, Wallace D, Croxford J, Lynch JH, White R, Walters BB. Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. JAMA Psychiatry. 2020 Feb 1;77(2):130-138. doi: 10.1001/jamapsychiatry.2019.3474.
PubMed 31693083Peterson K, Bourne D, Anderson J, Mackey K, Helfand M. Evidence Brief: Effectiveness of Stellate Ganglion Block for Treatment of Posttraumatic Stress Disorder (PTSD) [Internet]. Washington (DC): Department of Veterans Affairs (US); 2017 Feb. Available from http://www.ncbi.nlm.nih.gov/books/NBK442253/
PubMed 28742302
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder: Outcome Evaluation, Mechanism of Action, and Integration in Care - A Phase III Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05427500
- Acronym / sponsor ID
- 2022001
- Conditions
- PTSD
- Keywords
- Stellate Gangllion Block, Canadian Armed Forces, Veterans, Royal Canadian Mounted Police
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- The Royal's Institute of Mental Health ResearchUniversity, hospital or other
- Collaborators
- Ottawa Hospital Research Institute
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Jan 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 22 Jun 2022 (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 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.
Detailed description
Posttraumatic Stress Disorder (PTSD) is a trauma- and stress-related disorder arising from an experienced or witnessed traumatic event, most commonly actual or threatened death, serious injury, or sexual violence. There is a distinct pattern of intrusion and avoidance, as well as negative alterations in cognitions, mood, arousal, and reactivity, leading to serious impairments in personal, social and occupational functioning. The risk of PTSD is elevated in military and public safety personnel, and first responders. Despite advances in evidence-based treatments for PTSD, optimal outcomes are often not achieved, particularly in military veterans. One of the treatment-interfering factors is persistent hyperarousal (abnormally heightened state of anxiety and alertness), which prevents engagement in trauma processing and contributes to medication intolerance and substance misuse. The search for novel methods to target hyperarousal and underlying responses of the sympathetic nervous system have provided some promising pharmacologic approaches, such as the use of the adrenergic (adrenaline-related) blockers propranolol and prazosin. There is a need for novel and complementary approaches to normalize sympathetic (fight-or-flight) regulation in PTSD to provide symptom relief and facilitate its treatment and recovery.
Stellate ganglion block (SGB) is a medical procedure that involves injection of local anesthetic around the stellate ganglion, which is a collection of sympathetic (fight-or-flight) nerves near the base of the neck (C6-7). This procedure causes a short-lived shutdown of sympathetic nerve signals (up to 5-7 hours) and is commonly performed in Canada for certain pain and medical conditions. SGB is an interventional procedure that temporarily blocks sympathetic signaling to the arms, neck and head with long-established therapeutic benefits for sympathetically maintained pain and other medical conditions. In the past decade, SGB was found to provide a rapid and sustained reduction of PTSD symptoms in numerous case reports and series. Further, two randomized controlled trials of SGB in PTSD have been conducted. The first study in active and retired military personnel with combat and non-combat PTSD did not differentiate the effect of SGB from sham control one week or one month post-injection , although these results were inconclusive due to methodological limitations. The second study in active-duty military personnel established substantial efficacy of SGB that was administered twice in a 2-week interval when assessed at eight weeks after the first injection . Notably, most of the studies above were conducted in predominantly male active-duty military samples and none specifically in veterans, law enforcement officers, or first responders. Considering these results and the known safety of this procedure, SGB has been increasingly used to treat PTSD in the United States Veterans Affairs (VA) system, but has not yet been evaluated in Canada.
The mechanism of action of SGB in PTSD is not well understood. Presumably, SGB directly reduces peripheral sympathetic tone but may also project to the central nervous system to activate neuroplasticity processes. The current consensus is that SGB has a unique adjunct potential in PTSD treatment, but the parameters of its use and mechanism of action require further study. In order to enhance care and in response to requests from our patients and their clinicians, we initiated a collaboration between the OSI and TOH Pain clinics to facilitate access to SGB for our patients, particularly those who are not improving with traditional therapies because of intractable hyperarousal and anxiety. To date, 15 patients have undergone off-label SGB procedures at The Ottawa Hospital (TOH) Pain Clinic, seven for whom we have clinical data up to eight weeks post-SGB. We are still collecting follow-up data for the other eight patients, who had the procedure done more recently. Of those seven who underwent SGB procedures prior to October 2021, five were responders on the PTSD Checklist for DSM-5 (PCL-5), as evidenced by a 10-point decrease in the total score, between one week pre-SGB and eight weeks post-SGB. Mean Quick Inventory of Depressive Symptomatology (QIDS-SR) scores decreased from the severe to moderate range. Within 2 weeks of the procedure, one patient commented that he had "less anxiety, no panic attacks," and another reported, "It was like the entire planet felt less menacing and I felt calmer than I had in years." There were no serious adverse events related to the SGB procedure. In summary, current treatments for PTSD have shortcomings and less success in military veterans. One of the most significant challenges for recovery from PTSD is an overactive "fight-or-flight" state, fueled by the sympathetic nervous system. Patients struggle with near constant hyperarousal as they are in a state of physical and mental readiness to react to a threat. While this reaction is appropriate in dangerous situations, as a symptom of PTSD, it becomes excessive and uncontrollable, leading to persistent anxiety, irritability, agitation, startle, and sleep problems as well as triggering traumatic memories and standing in the way of regular life activities. Currently, even the best treatments for PTSD do not directly reduce hyperarousal or sympathetic activity, making it more difficult for patients to engage in and benefit from trauma-focused therapy or medications. Sufferers are often prompted to self-medicate with alcohol and other substances, which also negatively impact the patient's family and support network. This significant treatment gap calls for exploring novel ways to lessen the entrenched "fight or flight" state in those with PTSD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single SGB | Other | Drug: 5 mL of 0.5% preservative-free bupivacaineThis arm will receive a single 5 mL dose of 0.5% preservative-free bupivacaine. |
| Repeated SGB | Other | Drug: 5 mL of 0.5% preservative-free bupivacaineThis arm will receive two 5 mL doses of 0.5% preservative-free bupivacaine. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of PTSD according to DSM-5 criteria with prominent and persistent cluster E hyperarousal symptoms
- Age 18-69 years
- Under care of a mental health clinician
- Not benefited from adequate trials of pharmacological or psychological evidence-based treatment and/or a preference and consent for a trial of SGB
Key exclusion criteria (23 listed)
- Assessed with high risk for suicide in the last 30 days (per patient's treating clinician at OSI clinic)
- Diagnosis of bipolar or psychotic disorder
- Moderate to severe substance use within the last 30 days (based on chart and verbal report from patient)
- In process of disability assessment or legal action
- Moderate or severe TBI (based on chart and verbal report from patient)
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 |
|---|---|---|
| 5 mL of 0.5% preservative-free bupivacaineAlso: SteriMax BupivicaineIV will be inserted. Patient will be connected to cardiorespiratory monitors. The neck will be cleansed twice. A high frequency (15-6 MHz) linear ultrasound probe will be used to identify the arteries, jugular vein, and other important vasculature. Once a clear path for the needle is identified, the skin is anesthetized. A cutting tip spinal needle is then inserted at the lateral aspect of the field and advanced in-plane under ultrasound visualization. A test injection is injected to verify placement, then 5 mL of 0.5% preservative-free bupivacaine will be injected. Per standard SGB procedure, vitals will be measured post-SGB and participants will remain in the clinic for approximately 15 minutes to monitor for any serious adverse events. | Drug | Repeated SGB, Single SGB |
Primary outcome
Monitoring patient response and remission of PTSD symptoms
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Proportion of patients showing response (at least 10-point reduction) and remission (total score < 33) in symptoms of PTSD on PCL-5
Monitoring patient improvement on Clinician Administered PTDS Scale for DSM-5 (CAPS-5)
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Proportion of patients showing response (at least 10-points reduction) and loss of diagnosis on CAPS-5
Monitoring patient improvement in symptom burden and functioning
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
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
6 secondary outcomes
Changes from baseline in hypervigilance
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Changes from baseline in anxiety
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Changes from baseline in depression
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Changes from baseline in pain scale scores
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Ratings of participant satisfaction and recommendations for future use of SGB
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
Changes in participant's symptomatology and overall functioning from the perspective of the participant's family and support network
Time frame: From pre-SGB to final study visit 12-weeks post procedure.
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 25 Jul 2025.
- BackgroundAmerican Psychiatric Association, DSM-5 Task Force. (2013). Diagnostic and Statistical Manual of Mental Disorders: DSM-5™ (5th ed.). American Psychiatric Publishing, Inc
- Background: PubMed 26241600Steenkamp MM, Litz BT, Hoge CW, Marmar CR. Psychotherapy for Military-Related PTSD: A Review of Randomized Clinical Trials. JAMA. 2015 Aug 4;314(5):489-500. doi: 10.1001/jama.2015.8370.
- Background: PubMed 28454621Krystal JH, Davis LL, Neylan TC, A Raskind M, Schnurr PP, Stein MB, Vessicchio J, Shiner B, Gleason TC, Huang GD. It Is Time to Address the Crisis in the Pharmacotherapy of Posttraumatic Stress Disorder: A Consensus Statement of the PTSD Psychopharmacology Working Group. Biol Psychiatry. 2017 Oct 1;82(7):e51-e59. doi: 10.1016/j.biopsych.2017.03.007. Epub 2017 Mar 14. No abstract available.
- Background: PubMed 21813436Hoge CW. Interventions for war-related posttraumatic stress disorder: meeting veterans where they are. JAMA. 2011 Aug 3;306(5):549-51. doi: 10.1001/jama.2011.1096. No abstract available.
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- Background: PubMed 32255250Aleanakian R, Chung BY, Feldmann RE Jr, Benrath J. Effectiveness, Safety, and Predictive Potential in Ultrasound-Guided Stellate Ganglion Blockades for the Treatment of Sympathetically Maintained Pain. Pain Pract. 2020 Jul;20(6):626-638. doi: 10.1111/papr.12892. Epub 2020 May 17.
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- Individual participant dataSharing planned: No
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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 Gomez, MD principal investigator
Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 5 mL of 0.5% preservative-free bupivacaine in people with 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 23 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: enrolling by invitation, as of the sponsor's last update on 25 Jul 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring patient response and remission of PTSD symptoms (time frame: From pre-SGB to final study visit 12-weeks post procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05427500, which also lists 12 linked publications.
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 25 Jul 2025; AzTrials last refreshed its copy on 8 Nov 2026.