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Inferior Vena Cava (IVC) Diameters Before & After Interscalene Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03989076
Recruitment Status : Recruiting
First Posted : June 18, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Rodney Gabriel, University of California, San Diego

Brief Summary:
The purpose of this study is to understand how changes to breathing patterns in the chest affect blood flow to the heart from the inferior vena cava in the abdomen. Ultrasound of the upper abdomen will be used to visualize changes in breathing patterns in the chest and blood flow in the abdomen.

Condition or disease Intervention/treatment
IVC - Inferior Vena Cava Abnormality Procedure: Interscalene Brachial Plexus Block

Detailed Description:
In recent practice, point-of-care ultrasound has been used to assess the size and respiratory variation of the inferior vena cava as a marker for volume status and fluid responsiveness. Little investigation has occurred regarding the mechanism of observed respiratory variation. Anesthetic plans for surgery (e.g. shoulder replacement) frequently employ interscalene injections to target and block the brachial plexus, which (on the same side) results in phrenic nerve palsy and paralysis of the diaphragm. The goal of this study is to examine the relationship between diaphragmatic function and variation in IVC diameter. Specifically, the investigators will evaluate and compare the size and variability of the inferior vena cava by point-of-care ultrasound before and after brachial plexus block.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Evaluating the Mechanism of Changes to Inferior Vena Cava Diameter Using Point of Care Ultrasound in Patients Undergoing Interscalene Brachial Plexus Block
Actual Study Start Date : April 12, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


Intervention Details:
  • Procedure: Interscalene Brachial Plexus Block
    Analgesic nerve block as part of routine care with pre- and post-block ultrasonographic imaging of the diaphragm and inferior vena cava
    Other Name: Point of Care Ultrasound


Primary Outcome Measures :
  1. Ipsilateral hemiparesis [ Time Frame: Within 30 minutes post-block ]
    Detectable paralysis of the ipsilateral hemidiaphragm by point of care ultrasound

  2. IVC Collapsibility Index Change [ Time Frame: Within 30 minutes post-block ]
    Measured IVC diameter and collapsibility by point of care ultrasound



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult (age > 18 years) patients undergoing surgery of any type at UC San Diego Medical Center for whom the surgeon has requested an interscalene nerve block and for whom the block is clinically indicated as determined by the primary anesthesiologist.
Criteria

Inclusion Criteria:

  • Adult (age > 18 years)
  • Scheduled to receive an interscalene block

Exclusion Criteria:

  • Any person with known, pre-existing phrenic nerve, diaphragmatic, or inferior vena cava anomaly.
  • Patients who cannot be successfully imaged by ultrasound or who cannot participate in spirometry will additionally be excluded.
  • Non-English speaking patients will be excluded as well as there is no research funding to translate consent forms. Given that there is no potential benefit to participation in the study, this does not exclude these individuals from any potentially beneficial therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03989076


Locations
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United States, California
UCSD Medical Center Recruiting
La Jolla, California, United States, 92037
Contact: Rodney Gabriel, MD    858-249-3660    ragabriel@ucsd.edu   
Sponsors and Collaborators
University of California, San Diego
Publications:

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Responsible Party: Rodney Gabriel, Principal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03989076    
Other Study ID Numbers: UCSD 181482
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Congenital Abnormalities