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NCT04209504 · ClinicalTrials.gov registry record

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

A clinical trial of Shoulder Pain and Rotator Cuff Tears, sponsored by Duke University.

Recruiting
Registry status
60
Enrollment target
1
Study location

NCT04209504 is a study of Shoulder Pain and Rotator Cuff Tears that is actively recruiting participants, run by Duke University. The registered enrollment target is 60 participants, below the 99-participant average among 27 other Shoulder Pain trials with a reported enrollment target (39% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT04209504, a study of Shoulder Pain and Rotator Cuff Tears, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
60 participants
Enrollment target
1
Study location

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 Studied

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

Interventions

  • DRUG Bupivacaine
  • DIAGNOSTIC_TEST Ultrasound
  • DRUG Ropivacaine
  • DEVICE MediPines AGM100 Advanced Respiratory Monitoring System

Study Locations (1)

North Carolina

  • Duke University Hospital - Durham

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2021-10-12
Est. Completion 2026-08-31

Sponsor

Duke University

1,725 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04209504

The ClinicalTrials.gov registry entry for NCT04209504 describes a study currently listed as recruiting, categorized as an unspecified phase. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 99-participant average among 27 other Shoulder Pain trials with a reported enrollment target (39% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Shoulder Pain appearing as the primary indexed condition, and to 4 interventions - of which Bupivacaine is the first listed.

NCT04209504 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT04209504 about?

NCT04209504 is a clinical study titled "Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block". 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 i...

What is the current status of trial NCT04209504?

This trial is currently recruiting. The enrollment target is 60 participants. The study started on 2021-10-12. Estimated completion is 2026-08-31.

What conditions does trial NCT04209504 study?

This clinical trial studies the following conditions: Shoulder Pain, Rotator Cuff Tears, Rotator Cuff Injuries, Shoulder Injuries, Shoulder Arthritis.

What interventions are being tested in trial NCT04209504?

The interventions under investigation include: Bupivacaine (DRUG), Ultrasound (DIAGNOSTIC_TEST), Ropivacaine (DRUG), MediPines AGM100 Advanced Respiratory Monitoring System (DEVICE).

Who is sponsoring clinical trial NCT04209504?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04209504 being conducted?

This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.