Stellate Ganglion Block for Post-Traumatic Stress Disorder

Overseen By Ana Varela

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: NYU Langone Health

Must not be taking: Opioids, Cocaine, Benzodiazepines

Disqualifiers: Bipolar, Psychotic disorder, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

Duration: 1 day

90 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a treatment where a numbing medicine is injected into the neck to help patients with PTSD by blocking nerve signals. The goal is to see if this can reduce PTSD symptoms.

Will I have to stop taking my current medications?

The trial requires that your medications have been stable for 3 or more months before joining, except for benzodiazepines, which you cannot use. If you are currently taking benzodiazepines, you will need to stop.

What data supports the effectiveness of the treatment Stellate Ganglion Block for Post-Traumatic Stress Disorder?

Research shows that stellate ganglion block (SGB) has been successfully used to reduce symptoms of post-traumatic stress disorder (PTSD) in multiple studies, including a large trial and several case series. This treatment involves an injection in the neck that helps calm the body's stress response, and it has been effective in both combat-related and general PTSD cases. ^{1 2 3 4 5}

Is Stellate Ganglion Block using Bupivacaine safe for humans?

Bupivacaine (also known as Marcaine or Sensorcaine) is generally considered safe when used as a local anesthetic in various medical procedures, including epidural anesthesia and postoperative pain relief, with minimal side effects if dose recommendations are followed. ^{6 7 8 9 10}

How is stellate ganglion block treatment different for PTSD?

Stellate ganglion block (SGB) is unique for treating PTSD because it involves an injection of a local anesthetic in the neck to temporarily block nerves that control the body's fight-or-flight response, providing immediate relief. Unlike traditional PTSD treatments like therapy or medication, SGB is a quick outpatient procedure that can be effective right away. ^{1 2 3 4 5}

Research Team

Paul Glimcher, PhD

Principal Investigator

NYU Langone Health

Eligibility Criteria

Adults aged 18-65 with chronic PTSD, as defined by DSM-5, and a CAPS-5 score of at least 26 can join. Participants must have been on stable medication for three months (excluding benzodiazepines) and be able to consent. Exclusions include allergies to certain anesthetics or contrast agents, severe mental health or substance use disorders, past stellate ganglion block treatment, pregnancy, neck surgeries, metal implants affecting MRI safety, current opioid/cocaine/benzodiazepine use, cancer diagnosis among others.

Inclusion Criteria

Willing and able to provide informed consent

CAPS-5 Past Month score ≥ 26

Meets current DSM-5 PTSD diagnosis

Exclusion Criteria

I have been diagnosed with bipolar I disorder and had a manic episode in the past year.

Unable to take 7 days off of blood thinners

I have had a stellate ganglion block procedure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Pre-intervention

Participants undergo a pre-intervention fMRI scan and are randomized into treatment and placebo arms

1 week

1 visit (in-person)

Treatment

Treatment group receives stellate ganglion block; placebo group receives saline injection

1 day

1 visit (in-person)

Post-intervention Assessment

Participants undergo a post-intervention clinical assessment and fMRI scan

4 weeks post-procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

11 weeks

1 visit (in-person)

Treatment Details

Interventions

• Bupivacaine
• Saline

Trial Overview The trial is testing the effects of a stellate ganglion block injection in treating PTSD symptoms. Participants will receive either bupivacaine (anesthetic) or saline (placebo) injections under ultrasound guidance. The study includes initial screening and fMRI scans before and after the intervention to assess changes in brain function related to PTSD.

Participant Groups

Group I: Stellate Ganglion Block (SGB) Group Experimental Treatment 1 Intervention

Group II: Control Group Placebo Group 1 Intervention

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

This multisite, randomized clinical trial involving 113 active-duty service members demonstrated that two stellate ganglion block (SGB) treatments significantly reduced PTSD symptoms, with an average decrease of 12.6 points on the CAPS-5 scale compared to 6.1 points in the sham group.

The study suggests that SGB could be an effective adjunct treatment for PTSD, although the mild-moderate baseline severity of symptoms and short follow-up period may limit the broader applicability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. Rae Olmsted, KL., Bartoszek, M., Mulvaney, S., et al.[2021]

Stellate ganglion blocks (SGBs) at the C6 level provided immediate and significant relief from PTSD symptoms in two soldiers, as evidenced by a substantial drop in their Post-traumatic Stress Disorder Checklist (PCL) scores after treatment.

Both patients were able to discontinue their antidepressant and antipsychotic medications while maintaining their improved mental health, suggesting that SGBs may offer a safe and effective alternative treatment for PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of stellate ganglion block in the treatment of panic/anxiety symptoms with combat-related post-traumatic stress disorder; preliminary results of long-term follow-up: a case series. Mulvaney, SW., McLean, B., de Leeuw, J.[2022]

In a study of 205 patients with PTSD, 10 patients who did not respond to a right-sided stellate ganglion block (SGB) showed a remarkable 90% improvement in symptoms after receiving a left-sided SGB, with an average improvement of 28.3 points on the PTSD Checklist (PCL-5).

This suggests that left-sided SGB may be an effective alternative treatment for PTSD symptoms in patients who do not respond to right-sided SGB, highlighting the potential for tailored approaches in managing PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Successful Use of Left-sided Stellate Ganglion Block in Patients That Fail to Respond to Right-sided Stellate Ganglion Block for the Treatment of Post-traumatic Stress Disorder Symptoms: A Retrospective Analysis of 205 Patients. Mulvaney, SW., Lynch, JH., Curtis, KE., et al.[2022]

In a study of 166 active duty service members with PTSD symptoms, over 70% experienced significant improvement in anxiety symptoms following stellate ganglion blocks (SGB), with effects lasting beyond 3 to 6 months.

The SGB procedure, performed at the C6 level, is considered safe and minimally invasive, offering a promising treatment option for managing PTSD-related anxiety in military personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mulvaney, SW., Lynch, JH., Hickey, MJ., et al.[2018]

In a study of 11 patients with PTSD, stellate ganglion block (SGB) treatment led to significant improvements in PTSD symptoms, with an average reduction of 29 points on the PTSD Checklist-Military.

Importantly, SGB did not result in any decline in neurocognitive performance, and four out of eight cognitive measures showed trends of improvement, suggesting it is a safe and effective treatment option for individuals in high-stress environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurocognitive Performance is Not Degraded After Stellate Ganglion Block Treatment for Post-Traumatic Stress Disorder: A Case Series. Mulvaney, SW., Lynch, JH., de Leeuw, J., et al.[2017]

Bupivacaine (Marcaine) is effective for epidural analgesia in obstetrics, providing excellent sensory block with minimal impact on motor function and few side effects for both mothers and newborns.

When used at concentrations below 0.5%, and with careful dosing during labor, the risk of side effects and toxicity is low, and significant effects on newborns are rare due to the drug's high protein binding limiting its transfer across the placenta.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. Seebacher, J., Chareire, F., Galli-Douant, P., et al.[2013]

In a study involving 30 patients, two forms of 0.5% bupivacaine hydrochloride (Anecaine and Marcaine) were compared for epidural anesthesia, revealing differences in how quickly and effectively they provided pain relief.

Anecaine showed a shorter onset of analgesia at the catheter site but a delayed effect in peripheral areas compared to Marcaine, indicating that even the same active ingredient can behave differently based on the manufacturer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. Kozlov, SP., Vashchinskaia, TV., Svetlov, VA.[2013]

Instilling 0.5% bupivacaine directly into the surgical wound before closure is a safe and effective method for significantly reducing postoperative foot pain.

This technique offers a practical alternative to oral narcotics and parenteral agents, minimizing side effects and the need for complex administration methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. Bourne, MH., Johnson, KA.[2019]

Bupivacaine with a vasoconstrictor has a shorter onset time for local anesthesia compared to bupivacaine without a vasoconstrictor, but the duration of anesthesia is longer without the vasoconstrictor.

Using bupivacaine without a vasoconstrictor resulted in lower postoperative pain levels and better blood circulation, which is beneficial for the osseointegration of dental implants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. Duka, M., Lazić, Z., Stamatović, N., et al.[2019]

In a study comparing local anesthetics in rams, bupivacaine (BUPI) provided the longest duration of anesthesia (about 110 minutes) compared to lidocaine (LIDO) which lasted around 40 minutes, indicating BUPI's superior efficacy for longer procedures.

The combination of lidocaine and bupivacaine (LIDO-BUPI) did not offer any significant advantages over using bupivacaine alone, as it resulted in a similar duration of anesthesia (approximately 87 minutes).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing lidocaine, bupivacaine and a lidocaine-bupivacaine mixture as a metacarpal block in sheep. Lizarraga, I., Janovyak, E., Beths, T.[2013]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of Stellate Ganglion Block Treatment on Posttraumatic Stress Disorder Symptoms: A Randomized Clinical Trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

The use of stellate ganglion block in the treatment of panic/anxiety symptoms with combat-related post-traumatic stress disorder; preliminary results of long-term follow-up: a case series. [2022]

3. England pubmed.ncbi.nlm.nih.gov

The Successful Use of Left-sided Stellate Ganglion Block in Patients That Fail to Respond to Right-sided Stellate Ganglion Block for the Treatment of Post-traumatic Stress Disorder Symptoms: A Retrospective Analysis of 205 Patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Neurocognitive Performance is Not Degraded After Stellate Ganglion Block Treatment for Post-Traumatic Stress Disorder: A Case Series. [2017]

6. France pubmed.ncbi.nlm.nih.gov

[The use of Marcaine in obstetrical analgesia]. [2013]

7. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[A clinical trial of the use of 2 forms of bupivacaine hydrochloride (Anecaine and Marcaine) for epidural anesthesia]. [2013]

8. United States pubmed.ncbi.nlm.nih.gov

Postoperative pain relief using local anesthetic instillation. [2019]

9. Serbia pubmed.ncbi.nlm.nih.gov

Clinical parameters of the local anesthetic effects of bupivacaine applied with and without a vasoconstrictor in oral implantology. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Comparing lidocaine, bupivacaine and a lidocaine-bupivacaine mixture as a metacarpal block in sheep. [2013]