Stellate Ganglion Blockade in Corona Virus 2019 (COVID-19) Positive Patients

Phase 1

Terminated

Brief Summary: This study will establish the safety and efficacy of using stellate ganglion blocks in patients with acute respiratory distress syndrome (ARDS) due to COVID-19 disease.

Detailed Description: The stellate ganglion block (SGB) will be performed in the ICU. Nurse will provide patient monitoring and assistance during the procedure. Standard monitors and advanced cardiovascular life support (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 sodium phosphate (PF) 5mg, and 0.25% bupivacaine 5 ml is delivered. An ONQ brand 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.

Recruitment & Eligibility

Inclusion Criteria

Any patient between the ages of 19-85 with laboratory established COVID-19 infection via Real-Time Reverse Transcription-Polymerase Chain Reaction (rRT-PCR) requiring critical care in an intensive care unit.
Signs or symptoms consistent with ARDS must be present.
The syndrome must present acutely, ratio of arterial oxygen partial pressure to fractional inspired oxygen (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/acute respiratory distress syndrome (ARDS)
uncorrectable coagulopathy, already on Extracorporeal membrane oxygenation (ECMO), already on Nitric Oxide, pre-existing multi-organ failure (>2 organ systems).

Arm && Interventions

Group	Intervention	Description
Open Label SGB	Stellate Ganglion Block	Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.
Open Label SGB	Stellate Ganglion Block	Initial perineural bolus injection - clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml will be used for SGB block.

Primary Outcome Measures

Name	Time	Method
Evaluate the Safety of a New Modified Stellate Ganglia Block (SGB) in Acute Respiratory Distress Syndrome (ARDS)	3 month	a) differences in mean/median values for SGB vs standard of care (SOC) will be assessed at each of the study designated time points for all the continuous biomarker measures - by assessing magnitude of difference and its 95% confidence level and testing differences for statistical significance at each of the time points;

Secondary Outcome Measures

Name	Time	Method
Evaluating Stellate Ganglion Block Adverse Events.	3 month	e) Differences between SGB vs SOC in frequency and time to occurrence of cardiac arrhythmias;