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

December 6, 2024 updated by: University of Nebraska

Stellate Ganglion Blockade in COVID-19 Positive Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.
Drug: Stellate Ganglion Block

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).

Other Names:
  • Catapres, Decadron & Marcaine administration
No Intervention: Control Arm
There will be no sham procedure for the control group. The control group will have nitric oxide levels performed once a day by a member of the research team. Lab draws will be drawn at the same frequency as the treatment group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the Safety of a New Modified Stellate Ganglia Block (SGB) in Acute Respiratory Distress Syndrome (ARDS)
Time Frame: 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;
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluating Stellate Ganglion Block Adverse Events.
Time Frame: 3 month
e) Differences between SGB vs SOC in frequency and time to occurrence of cardiac arrhythmias;
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nebraska

Investigators

  • Principal Investigator: Michael Lankhorst, MD, University of Nebraska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2020

Primary Completion (Actual)

October 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 22, 2020

First Posted (Actual)

June 24, 2020

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 6, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0523-20-FB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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