What side effects are associated with this type of intervention?

Stellate Ganglion Block (SGB) is a treatment being studied for Post-COVID Syndrome that involves interrupting the sympathetic nervous system. Known side effects of SGB can include temporary pain at the injection site, bruising, infection, and in rare cases, nerve damage. Other treatments for Post-COVID Syndrome, such as physical therapy and medications for symptom management, may have side effects like fatigue, dizziness, and gastrointestinal issues. It is important to discuss potential risks and benefits with a healthcare provider.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved treatments for Post-COVID Syndrome that are mentioned in the provided context. The Stellate Ganglion Block, which is being studied for its potential to alleviate sympathetically-mediated symptoms of long COVID, is a procedure that interrupts sympathetic nervous system activity. This type of treatment is still under investigation, and no related drugs or similar treatments have been highlighted as FDA-approved for this condition.

What other types of research exist?

Promising novel alternatives to Stellate Ganglion Block for Post-COVID Syndrome patients include: 1) Vagus Nerve Stimulation (VNS), which has shown potential in modulating the autonomic nervous system and reducing inflammation. 2) Transcutaneous Electrical Nerve Stimulation (TENS), which may help alleviate pain and improve autonomic function. 3) Pharmacological interventions such as beta-blockers or alpha-2 agonists, which can help manage sympathetic overactivity. 4) Mind-body therapies like biofeedback and mindfulness-based stress reduction, which can help regulate autonomic responses and improve overall well-being.

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Nerve Block for Long COVID (DSBLongCOVID Trial)

Phase 1

Waitlist Available

Research Sponsored by Megan Nicklay

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing stellate ganglion blocks, which involve injecting a numbing medicine near nerves in the neck. The treatment aims to help patients with long COVID who have ongoing symptoms that don't respond to usual treatments. By blocking nerve signals, it may reduce pain and other issues linked to overactive nerves. Stellate ganglion block (SGB) is an anesthetic treatment initially used for pain relief and has shown promise in treating severe and chronic PTSD.

Who is the study for?

This trial is for adults who've had COVID-19 and are now suffering from long-term symptoms like low blood pressure, digestive issues, or pain. They must have confirmed past COVID-19 with a test and ongoing symptoms for at least four weeks. People can't join if they're on blood thinners, have glaucoma, previous similar treatments, local anesthetic allergies, are pregnant, or have infections/masses where the injection would go.

What is being tested?

The study is testing whether injecting a numbing medication called bupivacaine into nerves in the neck (stellate ganglion block) helps relieve chronic symptoms that some people experience after COVID-19.

What are the potential side effects?

Possible side effects of the stellate ganglion block may include soreness at the injection site, light-headedness due to low blood pressure, difficulty swallowing temporarily and very rarely seizure if the drug spreads to nearby structures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ability to participate in social roles and activities status

Anxiety

Depression

+5 more

Secondary study objectives

Autonomic Symptoms: COMPASS-31 Score

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ActiveExperimental Treatment1 Intervention

This is a non-randomized, non-blinded study. Participants eligible for this study will receive active treatment. Dual Sympathetic Blocks of the stellate ganglion are minimally- invasive outpatient procedures performed under monitored care anesthesia (light sedation). Under ultrasound visualization, a small needle is guided into the neck region that contains the stellate ganglion nerve cluster at C6-C7. Once the needle position is confirmed, a local anesthetic (7 cc of 0.5% bupivacaine/Marcaine) is injected around the stellate ganglion by the Principal Investigator. This procedure is repeated at the C3-C4 level to block the superior cervical ganglion nerve cluster (3 cc of 0.5% bupivacaine/Marcaine).

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Stellate Ganglion Block (SGB) is a treatment being studied for Post-COVID Syndrome that works by interrupting the sympathetic nervous system activity. This is achieved by injecting a local anesthetic near the stellate ganglion, a collection of nerves in the neck. By blocking these nerves, the treatment aims to reduce sympathetically-mediated symptoms such as chronic pain, fatigue, and other autonomic dysfunctions that are common in Post-COVID Syndrome. This matters for patients because it targets the underlying dysregulation of the autonomic nervous system, potentially providing relief from persistent and debilitating symptoms that are not adequately managed by other treatments.