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

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for people with PTSD (post-traumatic stress disorder) using a procedure called stellate ganglion block, which involves an injection to potentially ease symptoms. Participants will divide into two groups—one receiving the actual treatment (an injection of Bupivacaine, a local anesthetic) and another receiving a placebo. Researchers will use brain scans to compare the effects of both treatments before and after the procedure. Good candidates for this trial are individuals who have experienced PTSD symptoms for at least a month and have maintained stable medication plans for the past three months. As a Phase 4 trial, this research seeks to understand how the already FDA-approved and effective treatment can benefit more patients.

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 is the safety track record for these treatments?

Research has shown that the stellate ganglion block (SGB) using bupivacaine is generally safe. Studies focusing on SGB for treating post-traumatic stress disorder (PTSD), particularly in military personnel, have found no harm to brain function. Patients have not reported any major concerning side effects.

Bupivacaine, the anesthetic used in this treatment, is commonly used and usually safe. It blocks nerve signals in the neck area. While any procedure might carry some risks, such as temporary soreness or mild discomfort at the injection site, serious side effects have not been commonly reported in studies on SGB for PTSD.

This treatment is already in phase 4 trials, indicating a wealth of existing safety data in other settings. This suggests that any risks are likely known and manageable. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for PTSD, like cognitive-behavioral therapy and medications such as SSRIs, work by addressing symptoms over time through repeated sessions or regular dosing. But the Stellate Ganglion Block (SGB) offers a unique approach by using bupivacaine, an anesthetic, to target specific nerve clusters in the neck. This method can potentially provide rapid relief from PTSD symptoms by disrupting the nerve pathways involved in the stress response. Researchers are excited because SGB might offer quicker and more direct symptom relief compared to traditional methods, potentially transforming how PTSD is managed.

What evidence suggests that the stellate ganglion block is effective for PTSD?

Research has shown that a treatment called stellate ganglion block (SGB) using bupivacaine may help with post-traumatic stress disorder (PTSD). Studies have found that SGB can significantly reduce PTSD symptoms. Some patients reported feeling less anxious and stressed after receiving this treatment. Evidence suggests that SGB works by blocking certain nerve signals that contribute to PTSD symptoms. In this trial, participants in the Stellate Ganglion Block (SGB) Group will receive this treatment with bupivacaine, while the Control Group will receive a placebo. This treatment has shown enough promise to warrant further testing in phase 4 trials, which usually focus on treatments that are already approved. ^{1 2 4 6 7}

Who Is on the Research Team?

Paul Glimcher, PhD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

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]

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 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]

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]

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The Efficacy of Stellate Ganglion Block as Post-traumatic Stress Disorder (PTSD) ... making is that loss of PTSD diagnosis is a desired outcome.

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The focus of SGB now began to shift towards alleviation of post-traumatic stress symptoms, with a focus on the US military personnel returning from Iraq and ...

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Effects of Stellate Ganglion Block in Post-traumatic Stress Disorder · Overview · Trial locations · Eligibility criteria · Study plan · Outcome ...