Nerve Block for Long COVID

(DSBLongCOVID Trial)

Overseen By Megan Nicklay, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Megan Nicklay

Must not be taking: Anticoagulants

Disqualifiers: Under 18, Pregnancy, Glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 1 month

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using anticoagulants (blood thinners).

What data supports the effectiveness of the treatment Stellate Ganglion Block with 0.5% Bupivacaine for Long COVID?

Stellate ganglion block has been shown to provide pain relief in conditions like complex regional pain syndrome and to control blood pressure in patients with hypertension after surgery, suggesting its potential to help with symptoms in other conditions like Long COVID. ^{1 2 3 4 5}

Is the stellate ganglion block generally safe for humans?

Stellate ganglion block is generally considered safe, but rare complications can occur, such as seizures, breathing problems, and a condition called 'locked-in syndrome' where a person is conscious but cannot move or speak. These complications are usually due to incorrect injection, so careful monitoring and preparation are important during the procedure. ^{6 7 8 9 10}

How is the stellate ganglion block treatment for Long COVID different from other treatments?

The stellate ganglion block (SGB) treatment for Long COVID is unique because it involves injecting a local anesthetic, bupivacaine, near a nerve cluster in the neck to potentially relieve symptoms. This approach is different from other treatments as it targets the sympathetic nervous system, which may help with conditions like chronic pain and Long COVID, where standard treatments are not well-established. ^{3 4 5 6 11}

Research Team

Jonathann Kuo, MD

Principal Investigator

Medical Director

Eligibility Criteria

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.

Inclusion Criteria

You have reported specific symptoms related to your body's automatic functions on the COMPASS-31 screening test.

You have had a confirmed diagnosis of COVID-19 using a standard test.

Your pain levels, as reported by you, are measured using a specific test called PROMIS-29.

Exclusion Criteria

You are currently taking blood-thinning medication.

You have had glaucoma in the past.

You have undergone prior stereotactic body radiation therapy (SGB).

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive Dual Sympathetic Blocks of the stellate ganglion, performed at 0 and 1 weeks

1 month

2 visits (in-person)

Follow-up

Participants are monitored for changes in autonomic symptoms and patient-reported outcomes using PROMIS-29 and COMPASS-31 surveys

4 weeks

1 visit (virtual)

Treatment Details

Interventions

• Stellate Ganglion Block with 0.5% Bupivacaine

Trial Overview 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.

Participant Groups

Group I: Active Experimental Treatment 1 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).

Who Is Running the Clinical Trial?

Megan Nicklay

Lead Sponsor

Trials

1

Recruited

20+

Jonathann Kuo, MD

Lead Sponsor

Trials

1

Recruited

20+

References

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

A complication of stellate ganglion block? [2006]

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

Unilateral stellate block in the treatment of hypertension after coronary bypass surgery. Implications of a new therapeutic approach. [2019]

3. Turkey pubmed.ncbi.nlm.nih.gov

Efficacy of the Stellate Ganglion Block Through the Lateral Approach Using Ultrasonogram and Fluoroscopy. [2023]

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

Anterior cervical approach for stellate ganglion and T2 to T3 sympathetic blocks: a novel technique. [2006]

5. Nepal pubmed.ncbi.nlm.nih.gov

Ultrasound Guided Stellate Ganglion Block with Dexmedetomidine as an Adjuvant in Complex Regional Pain Syndrome (CRPS). [2021]

6. Ireland pubmed.ncbi.nlm.nih.gov

Ultrasound image guided lateral cervical approach to stellate ganglion block for cervical headache. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

[Complications and side effects of stellate ganglion blockade. Results of a questionnaire survey]. [2015]

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

Evaluation of Lung Function and Clinical Features of the Ultrasound-Guided Stellate Ganglion Block With 2 Different Concentrations of a Local Anesthetic: A Randomized Controlled Trial. [2018]

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

Fluoroscopic stellate ganglion block for postmastectomy pain: a comparison of the classic anterior approach and the oblique approach. [2013]

10. India pubmed.ncbi.nlm.nih.gov

Locked-in syndrome during stellate ganglion block. [2021]

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

A lateral percutaneous technique for stellate ganglion blockade in rats. [2017]