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Recruiting NCT04209504

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

— Observational Shoulder Surgery Shoulder Pain Shoulder Injuries Shoulder Arthritis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound, Ropivacaine, Bupivacaine, MediPines AGM100 Advanced Respiratory Monitoring System.
Who it may be relevant to
Registry conditions: Shoulder Surgery, Shoulder Pain, Shoulder Injuries, Shoulder Arthritis. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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 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 group 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. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.

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

Primary outcome measures

  • Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 [Time frame: 24 hours]
Secondary outcome measures (6)
  • Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3 [Time frame: up to 72 hours]
  • Noninvasive pulmonary measures of gas exchange [Time frame: up to 72 hours]
  • Pain scores [Time frame: up to 72 hours]
  • Opioid consumption [Time frame: up to 72 hours]
  • Hoarseness [Time frame: up to 72 hours]
  • Horner's Syndrome [Time frame: up to 72 hours]

Eligibility criteria

Inclusion criteria

  • English speaking 18-80 year old ASA 1-3 patients
  • Primary shoulder surgery
  • Must live within a 25 mile radius

Exclusion criteria

  • ASA 4 or 5
  • Revision shoulder surgery
  • Diagnosis of chronic pain
  • Daily chronic opioid use (over 3 months of continuous opioid use)
  • Inability to communicate pain scores or need for analgesia
  • Infection at the site of block placement
  • Age under 18 years old or greater than 80 years old
  • Pregnant women (as determined by point-of-care serum bHCG)
  • Intolerance/allergy to local anesthetics
  • Weight <50 kg
  • BMI > 40
  • severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
  • Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  • Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
  • Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Duke University Hospital — Durham

Identifiers

NCT: NCT04209504 · Pro00104053

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗