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

NCT04209504 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2025-10-01

No results posted yet for this study

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.

Conditions

  • Shoulder Surgery
  • Shoulder Pain
  • Shoulder Injuries
  • Shoulder Arthritis
  • Shoulder Disease
  • Rotator Cuff Tears
  • Rotator Cuff Injuries
  • Rotator Cuff Arthropathy of Left Shoulder
  • Rotator Cuff Arthropathy of Right Shoulder
  • Rotator Cuff Repair

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

Sponsors & Collaborators

Principal Investigators

  • Amanda Kumar, MD · Duke University

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-12
Primary Completion
2026-08-31
Completion
2026-08-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04209504 on ClinicalTrials.gov