Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

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: Recruiting study of Shoulder Pain and Rotator Cuff Tears, sponsored by Duke University.

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. According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

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.

Primary Outcome

Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1

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
Duke University

1,725 total trials

What NCT04209504 shows while recruiting

NCT04209504 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 99-participant average among 27 other Shoulder Pain trials with a reported enrollment target (39% lower).

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 a single indexed study location in 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.

Learn More About Clinical Trials

Similar trials for Shoulder Pain

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04209504's enrollment target sits among peer trials

60 13th of 27 higher than 14 of 27 other Shoulder Pain trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Shoulder Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar enrollment target

  • NCT00576069 · 60 participants

    Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma

  • NCT01297400 · 60 participants · Phase 2

    Phase 2 Pilot Study of the Safety and Efficacy of Topical MW-III in Thermal Burns

  • NCT01734122 · 60 participants

    Stereotactic Radiosurgery for Essential Tremor and Parkinsonian Tremor

  • NCT01804634 · 60 participants · Phase 2

    Reduced Intensity Haploidentical BMT for High Risk Solid Tumors

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

More recruiting context for NCT04209504

Source: ClinicalTrials.gov NCT04209504, the US trial registry maintained by the National Library of Medicine. NCT04209504 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.