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

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    60
  • sponsor
    Duke University
Updated on 22 November 2021
local anesthetic

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.

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.

Details
Condition TENDON INJURY, Arthralgia, disorder of shoulder, Shoulder Pain, Chronic Leg Pain, Trauma, Rotator Cuff Repair, Rotator Cuff Injuries, Shoulder Surgery, Shoulder Arthritis, Tendon Injuries, Rotator Cuff Arthropathy of Right Shoulder, Rotator Cuff Injury, Shoulder Injury, Rotator Cuff Arthropathy of Left Shoulder, Shoulder Disease, Wounds, Rotator Cuff Tear, Rotator Cuff Tears, Rotator Cuff Syndrome, Shoulder Injuries
Treatment ropivacaine, ultrasound, Bupivacaine, MediPines AGM100 Advanced Respiratory Monitoring System
Clinical Study IdentifierNCT04209504
SponsorDuke University
Last Modified on22 November 2021

Eligibility

Yes No Not Sure

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
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