Stellate Ganglion Block in the Treatment of Posttraumatic Stress Disorder

NCT05427500 | Enrolling By Invitation Phase 3

• 1 other identifier: 2022001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

PTSD

Keywords

Stellate Gangllion Block; Canadian Armed Forces; Veterans; Royal Canadian Mounted Police

Outcome Measures

Primary Outcomes (3)

• 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

  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

  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

  From pre-SGB to final study visit 12-weeks post procedure.

Secondary Outcomes (6)

• Changes from baseline in hypervigilance

  From pre-SGB to final study visit 12-weeks post procedure.

• Changes from baseline in anxiety

  From pre-SGB to final study visit 12-weeks post procedure.

• Changes from baseline in depression

  From pre-SGB to final study visit 12-weeks post procedure.

• Changes from baseline in pain scale scores

  From pre-SGB to final study visit 12-weeks post procedure.

• Ratings of participant satisfaction and recommendations for future use of SGB

  From pre-SGB to final study visit 12-weeks post procedure.

Study Arms (2)

Single SGB

OTHER

This arm will receive a single 5 mL dose of 0.5% preservative-free bupivacaine.

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.

Drug: 5 mL of 0.5% preservative-free bupivacaine

Interventions

5 mL of 0.5% preservative-free bupivacaine DRUG

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.

Also known as: SteriMax Bupivicaine

Repeated SGB; Single SGB

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• The Royal's Institute of Mental Health Research: lead
• Ottawa Hospital Research Institute: collaborator

Study Sites (1)

The Royal Ottawa Mental Health Centre

Ottawa, Ontario, K1Z 7K4, Canada

Location

Related Publications (12)

• American Psychiatric Association, DSM-5 Task Force. (2013). Diagnostic and Statistical Manual of Mental Disorders: DSM-5™ (5th ed.). American Psychiatric Publishing, Inc

  BACKGROUND

• 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.

  PMID: 26241600 BACKGROUND

• Krystal 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.

  PMID: 28454621 BACKGROUND

• Hoge 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.

  PMID: 21813436 BACKGROUND

• DePierro 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.

  PMID: 31466562 BACKGROUND

• Aleanakian 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.

  PMID: 32255250 BACKGROUND

• Lipov 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.

  PMID: 19034755 BACKGROUND

• Mulvaney 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.

  PMID: 25269132 BACKGROUND

• Lipov 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.

  PMID: 26073361 BACKGROUND

• Hanling 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.

  PMID: 27187898 BACKGROUND

• Rae 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.

  PMID: 31693083 BACKGROUND

• Peterson 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/

  PMID: 28742302 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Rebecca Gomez, MD

  Psychiatrist at the OSI Clinic at the Royal Ottawa Mental Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: June 22, 2022
• Study Start: March 30, 2024
• Primary Completion: January 30, 2026
• Study Completion (Estimated): January 30, 2027
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)