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

Evaluating the Mechanism of Changes to Inferior Vena Cava Diameter Using Point of Care Ultrasound in Patients Undergoing Interscalene Brachial Plexus Block

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.

Study Overview

• Status: Withdrawn
• Conditions: IVC - Inferior Vena Cava Abnormality
• Intervention / Treatment: 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.

• Study Type: Observational

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92037
      • UCSD Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ipsilateral hemiparesis	Detectable paralysis of the ipsilateral hemidiaphragm by point of care ultrasound	Within 30 minutes post-block
IVC Collapsibility Index Change	Measured IVC diameter and collapsibility by point of care ultrasound	Within 30 minutes post-block

Collaborators and Investigators

• Sponsor: University of California, San Diego

Publications and helpful links

General Publications

• Nagdev AD, Merchant RC, Tirado-Gonzalez A, Sisson CA, Murphy MC. Emergency department bedside ultrasonographic measurement of the caval index for noninvasive determination of low central venous pressure. Ann Emerg Med. 2010 Mar;55(3):290-5. doi: 10.1016/j.annemergmed.2009.04.021. Epub 2009 Jun 25.
• Feissel M, Michard F, Faller JP, Teboul JL. The respiratory variation in inferior vena cava diameter as a guide to fluid therapy. Intensive Care Med. 2004 Sep;30(9):1834-7. doi: 10.1007/s00134-004-2233-5. Epub 2004 Mar 25.
• Magder S. Bench-to-bedside review: An approach to hemodynamic monitoring--Guyton at the bedside. Crit Care. 2012 Oct 29;16(5):236. doi: 10.1186/cc11395.
• Kimura BJ, Dalugdugan R, Gilcrease GW 3rd, Phan JN, Showalter BK, Wolfson T. The effect of breathing manner on inferior vena caval diameter. Eur J Echocardiogr. 2011 Feb;12(2):120-3. doi: 10.1093/ejechocard/jeq157. Epub 2010 Oct 27.
• Gignon L, Roger C, Bastide S, Alonso S, Zieleskiewicz L, Quintard H, Zoric L, Bobbia X, Raux M, Leone M, Lefrant JY, Muller L. Influence of Diaphragmatic Motion on Inferior Vena Cava Diameter Respiratory Variations in Healthy Volunteers. Anesthesiology. 2016 Jun;124(6):1338-46. doi: 10.1097/ALN.0000000000001096.
• El-Boghdadly K, Chin KJ, Chan VWS. Phrenic Nerve Palsy and Regional Anesthesia for Shoulder Surgery: Anatomical, Physiologic, and Clinical Considerations. Anesthesiology. 2017 Jul;127(1):173-191. doi: 10.1097/ALN.0000000000001668.
• Boon AJ, Sekiguchi H, Harper CJ, Strommen JA, Ghahfarokhi LS, Watson JC, Sorenson EJ. Sensitivity and specificity of diagnostic ultrasound in the diagnosis of phrenic neuropathy. Neurology. 2014 Sep 30;83(14):1264-70. doi: 10.1212/WNL.0000000000000841. Epub 2014 Aug 27.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 12, 2019
• Primary Completion (ACTUAL): July 14, 2021
• Study Completion (ACTUAL): July 14, 2021

Study Registration Dates

• First Submitted: June 13, 2019
• First Submitted That Met QC Criteria: June 13, 2019
• First Posted (ACTUAL): June 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 21, 2021
• Last Update Submitted That Met QC Criteria: July 14, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: UCSD 181482

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No