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

Recruiting

• Conditions: Rotator Cuff Tears; Rotator Cuff Injuries; Shoulder Arthritis; Shoulder Disease; Shoulder Pain; Rotator Cuff Arthropathy of Left Shoulder; Rotator Cuff Arthropathy of Right Shoulder; Shoulder Surgery; Shoulder Injuries; Rotator Cuff Repair
• Interventions: Diagnostic Test: Ultrasound; Drug: Ropivacaine; Drug: Bupivacaine; Device: MediPines AGM100 Advanced Respiratory Monitoring System

• Registration Number: NCT04209504
• Lead Sponsor: Duke University

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.

Study Timeline

• Study First Submitted: 2019-12-20
• Study First Submitted QC: 2019-12-23
• Study First Posted: 2019-12-24
• Study Start: 2021-10-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-03
• Last Update Posted: 2025-02-04
• Primary Completion: 2025-08-31
• Study Completion: 2025-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Continuous Perineural Catheter	MediPines AGM100 Advanced Respiratory Monitoring System	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.
20 mL Liposomal Bupivacaine Single Shot	Ultrasound	Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
10 mL Liposomal Bupivacaine Single Shot	Ultrasound	Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
Continuous Perineural Catheter	Ultrasound	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.
10 mL Liposomal Bupivacaine Single Shot	MediPines AGM100 Advanced Respiratory Monitoring System	Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
20 mL Liposomal Bupivacaine Single Shot	MediPines AGM100 Advanced Respiratory Monitoring System	Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
Continuous Perineural Catheter	Ropivacaine	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.
10 mL Liposomal Bupivacaine Single Shot	Bupivacaine	Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
20 mL Liposomal Bupivacaine Single Shot	Bupivacaine	Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine

Primary Outcome Measures

Name	Time	Method
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1	24 hours	Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1

Secondary Outcome Measures

Name	Time	Method
Noninvasive pulmonary measures of gas exchange	up to 72 hours	Noninvasive pulmonary measures of gas exchange
Pain scores	up to 72 hours	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	up to 72 hours	Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3
Hoarseness	up to 72 hours	Incidence of recurrent laryngeal nerve palsy (subjective)
Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3	up to 72 hours	Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3
Horner's Syndrome	up to 72 hours	Incidence of Horner's Syndrome

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States