RecruitingNCT04209504

Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block


Sponsor

Duke University

Enrollment

60 participants

Start Date

Oct 12, 2021

Study Type

OBSERVATIONAL

Conditions

Summary

This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. English speaking American Society of Anesthesiologists (ASA) 1-3 patients ages 18-80 receiving prolonged interscalene nerve block will be randomized into 3 groups: first group receiving a perineural catheter infusing 0.2% ropivacaine; the second group receiving a single shot injection of 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine and the third receiving 20mL liposomal bupivacaine plus 5mL bupivacaine (to be determined by the attending anesthesiologist).Primary outcome will be incidence of hemidiaphragmatic paralysis postoperative day 1 as measured by point of care (POCUS) ultrasound.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Bupivacaine, a medical device called MediPines AGM100 Advanced Respiratory Monitoring System, and others for people with rotator cuff arthropathy of left shoulder, rotator cuff arthropathy of right shoulder, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTUltrasound

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

DRUGRopivacaine

Local anesthetic (numbing drug)

DRUGBupivacaine

Local anesthetic (numbing drug)

DEVICEMediPines AGM100 Advanced Respiratory Monitoring System

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters


Locations(1)

Duke University Hospital

Durham, North Carolina, United States

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NCT04209504


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