Stellate Ganglion Blockade in COVID-19 Positive Patients

Sponsor

University of Nebraska (Other)

Overall Status

Completed

CT.gov ID

NCT04445337

Collaborator

(none)

Enrollment

Location

Arm

11.5

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
COVID 19 ARDS	Procedure: Stellate Ganglion Block	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Open-label use of stellate ganglion block.Open-label use of stellate ganglion block.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stellate Ganglion Blockade in COVID-19 Positive Patients

Actual Study Start Date :

Nov 15, 2020

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Nov 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Open Label SGB 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 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.

Arm

Intervention/Treatment

Experimental: Open Label SGB

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

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.

Outcome Measures

Primary Outcome Measures

Evaluate the safety of a new modified stellate ganglia block (SGB) in ARDS [3 month]
Adverse events related to SGB.

Secondary Outcome Measures

Evaluate the efficacy of a new modified stellate ganglia block (SGB) in ARDS [3 month]
All adverse events.

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Nebraska Medical Center	Omaha	Nebraska	United States	68198

Sponsors and Collaborators

University of Nebraska

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Michael Lankhorst, Assistant Professor, University of Nebraska

ClinicalTrials.gov Identifier:

NCT04445337

Other Study ID Numbers:

603.20.FB

First Posted:

Jun 24, 2020

Last Update Posted:

May 24, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Michael Lankhorst, Assistant Professor, University of Nebraska

stellate ganglion

perineural block

Additional relevant MeSH terms:

COVID-19

Ganglion Cysts

Study Results

No Results Posted as of May 24, 2022