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

Withdrawn

• Conditions: IVC - Inferior Vena Cava Abnormality

• Registration Number: NCT03989076
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2019-04-12
• Study First Submitted: 2019-06-13
• Study First Submitted QC: 2019-06-13
• Study First Posted: 2019-06-18
• Status Verified: 2021-07
• Primary Completion: 2021-07-14
• Study Completion: 2021-07-14
• Last Update Submitted: 2021-07-14
• Last Update Posted: 2021-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

UCSD Medical Center; 🇺🇸 La Jolla, California, United States