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

Phase 1TerminatedNCT04445337

University of Nebraska1 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

COVID 19 ARDS

Interventions

Stellate Ganglion BlockDRUG

An injection of local anesthetic into the front of the neck. SGB involves placing a small tube into the front of your neck, toward nerves at the back of your neck. This is done with the help of an x-ray machine or ultrasound device. The tube is left in place so you can get medication thru it for five days. Then the tube is taken out. The medication used for the block are clonidine 100 mcg, Decadron PF 5mg and 0.25% bupivacaine 5 mL. This medication will be administered once during the block. These medications are approved by the Food and Drug Administration (FDA).

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 Years

Medical Language ↔ Plain English

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).

Locations (1)

University of Nebraska Medical Center

Omaha, Nebraska, United States

Outcomes

Primary Outcomes

Evaluate the Safety of a New Modified Stellate Ganglia Block (SGB) in Acute Respiratory Distress Syndrome (ARDS)

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;

Time frame: 3 month

Secondary Outcomes

Evaluating Stellate Ganglion Block Adverse Events.

e) Differences between SGB vs SOC in frequency and time to occurrence of cardiac arrhythmias;

Time frame: 3 month

Data from ClinicalTrials.gov

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