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

Duke University

Status: Enrolling

Conditions: Shoulder Pain; Shoulder Injuries; Shoulder Arthritis; Shoulder Surgery; Rotator Cuff Arthropathy of Left Shoulder; Rotator Cuff Arthropathy of Right Shoulder; Shoulder Disease; Rotator Cuff Repair; Rotator Cuff Injuries; Rotator Cuff Tears

Treatments: Drug: Ropivacaine; Diagnostic Test: Ultrasound; Device: MediPines AGM100 Advanced Respiratory Monitoring System; Drug: Bupivacaine

Study type: Observational

Funder types: Other

Identifiers

NCT04209504

Pro00104053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

Continuous Perineural Catheter

Description:

Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion.

Treatment:

Device: MediPines AGM100 Advanced Respiratory Monitoring System

Diagnostic Test: Ultrasound

Drug: Ropivacaine

10 mL Liposomal Bupivacaine Single Shot

Description:

Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

Treatment:

Drug: Bupivacaine

Device: MediPines AGM100 Advanced Respiratory Monitoring System

Diagnostic Test: Ultrasound

20 mL Liposomal Bupivacaine Single Shot

Description:

Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

Treatment:

Drug: Bupivacaine

Device: MediPines AGM100 Advanced Respiratory Monitoring System

Diagnostic Test: Ultrasound