Stellate Ganglion Blockade in COVID-19 Positive Patients

Study Overview
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Brief Summary
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This study will establish the safety and efficacy of using stellate ganglion blocks in patients with ARDS due to COVID-19 disease.

Detailed Description
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The attending proceduralist will perform the SGB in the ICU. Nurse will provide patient monitoring and assistance during the procedure. Standard monitors and ACLS resuscitative equipment will be immediately available. A norepinephrine solution will be at bedside to treat potential hypotension associated with SGB. The SGB perineural catheter will be placed using standard sterile technique. Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered. An OnQ perineural infusion 0.2% bupivacaine will be initiated at 2ml/hr for 5 days. Acute pain service will discontinue infusion and remove the catheter after 5 days.

Official Title
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Stellate Ganglion Blockade in COVID-19 Positive Patients

Conditions
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COVID 19, ARDS

Intervention / Treatment
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* Procedure: Stellate Ganglion Block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Any patient between the ages of 19-85 with laboratory established COVID-19 infection (via rRT-PCR) requiring critical care in an intensive care unit. Signs or symptoms consistent with ARDS must be present. The syndrome must present acutely, PaO2/FIO2 ≤ 200 mm Hg, bilateral infiltrates on chest radiograph or CT not due to cardiac failure, need for non-invasive or invasive mechanical ventilation, and any cardiac dysrhythmia (excluding sinus tachycardia). Exclusion Criteria: Hemodynamic instability (>2 vasopressors) pre-hospital diagnosis of heart failure or fluid overload anatomical inability to perform block prior sympathectomy patient currently enrolled in another clinical trial for COVID-19 or respiratory distress/ARDS uncorrectable coagulopathy, already on ECMO, already on Nitric Oxide, pre-existing multi-organ failure (>2 organ systems).

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open-label use of stellate ganglion block.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label SGB<br>Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block. | Procedure: Stellate Ganglion Block<br>* An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS | Adverse events related to SGB. | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS | All adverse events. | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stellate ganglion, perineural block