About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
English speaking 18-80 year old ASA 1-3 patients
Primary shoulder surgery
Must live within a 25 mile radius
Disqualifiers
ASA 4 or 5
Revision shoulder surgery
Diagnosis of chronic pain
Daily chronic opioid use (over 3 months of continuous opioid use)
Trial population
Patients ages 18-80 undergoing shoulder surgery per standard of care.
Trial design
Other
Prospective
Treatments tested in this trial
Ultrasound
Diagnostic testUltrasound guided evaluation of diaphragm ipsilateral to the block side.
Ropivacaine
DrugLocal anesthetic (numbing drug)
Bupivacaine
DrugLocal anesthetic (numbing drug)
MediPines AGM100 Advanced Respiratory Monitoring System
DeviceNon-invasive respiratory monitor to measure oxygenation and ventilation parameters
Treatment groups
Trial outcomes
Primary outcomes
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1
Secondary outcomes
Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3
Noninvasive pulmonary measures of gas exchange
Noninvasive pulmonary measures of gas exchange
Pain scores
Numerical Rating Scale (NRS) 11 pain scores (0-10; 0=no pain, 10=worst pain ever) at Post Anesthesia Care Unit (PACU), POD1, POD2, POD3
Opioid consumption
Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3
Sponsors and contacts
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