Clinical trial NCT04209504: Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Official title: Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Shoulder Surgery
Shoulder Pain
Shoulder Injuries
Shoulder Arthritis
Shoulder Disease
Rotator Cuff Tears
Rotator Cuff Injuries
Rotator Cuff Arthropathy of Left Shoulder
Rotator Cuff Arthropathy of Right Shoulder
Rotator Cuff Repair
Keywords: Rotator Cuff Repair
Shoulder Surgery
Hemidiaphragmatic paralysis
Interscalene Block
Interscalene Catheter
Interscalene Liposomal Bupivacaine
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients ages 18-80 undergoing shoulder surgery per standard of care.

Brief 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.

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.

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.

Primary outcomes:
measure: Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1
timeFrame: 24 hours
Secondary outcomes:
measure: Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3
timeFrame: up to 72 hours
measure: Noninvasive pulmonary measures of gas exchange
timeFrame: up to 72 hours
measure: Pain scores
timeFrame: up to 72 hours
measure: Opioid consumption
timeFrame: up to 72 hours
measure: Hoarseness
timeFrame: up to 72 hours
measure: Horner's Syndrome
timeFrame: up to 72 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Amanda Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References: