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

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04209504
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Ultrasound — DIAGNOSTIC_TEST
    Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
  • Ropivacaine — DRUG
    Local anesthetic (numbing drug)
  • Bupivacaine — DRUG
    Local anesthetic (numbing drug)
  • MediPines AGM100 Advanced Respiratory Monitoring System — DEVICE
    Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Study Details

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 Dates

Start date
Oct 12, 2021
Status verified
Sep 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Continuous Perineural Catheter
    Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.
  • Arm: 10 mL Liposomal Bupivacaine Single Shot
    Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
  • Arm: 20 mL Liposomal Bupivacaine Single Shot
    Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

Primary Outcome Measure

Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 [ Time Frame: 24 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke University HospitalDurhamNorth Carolina27710
William M Bullock, MD, PhD
[email protected]
919-681-6437
Amanda Kumar, MD
[email protected]
919-681-6437
Amanda Kumar, MD (PRINCIPAL_INVESTIGATOR)
William M Bullock, MD, PhD (SUB_INVESTIGATOR)
Jeff C Gadsden, MD (SUB_INVESTIGATOR)

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By research site
Duke University Hospital· Durham, NC

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