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RECRUITING
NCT04209504

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

Sponsor: Duke University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2021-10-12

Completion Date

2026-08-31

Last Updated

2025-10-01

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Ultrasound

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

DRUG

Ropivacaine

Local anesthetic (numbing drug)

DRUG

Bupivacaine

Local anesthetic (numbing drug)

DEVICE

MediPines 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