RecruitingNCT04209504

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

Sponsor

Duke University

Enrollment

60 participants

Start Date

Oct 12, 2021

Study Type

OBSERVATIONAL

Conditions

Shoulder Pain Rotator Cuff Tears Shoulder Injuries Shoulder Arthritis Shoulder Surgery Shoulder Disease

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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

Exclusion Criteria15

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.