Stellate Ganglion Blockade in COVID-19 Positive Patients

ARDS Clinical Trial

Official title:

Stellate Ganglion Blockade in COVID-19 Positive Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445337
• Other study ID #: 603.20.FB
• Status: Completed
• Phase: N/A
• Start date: November 15, 2020
• Est. completion date: November 1, 2021

Study information

• Verified date: May 2022
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: November 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• ARDS
• COVID 19
• COVID-19
• Ganglion Cysts

Intervention

Procedure:
• Stellate Ganglion Block
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.

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS	Adverse events related to SGB.	3 month
Secondary	Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS	All adverse events.	3 month