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

NCT04209504 | Recruiting

• 1 other identifier: Pro00104053
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1

  Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1

  24 hours

Secondary Outcomes (6)

• Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3

  up to 72 hours

• Noninvasive pulmonary measures of gas exchange

  up to 72 hours

• Pain scores

  up to 72 hours

• Opioid consumption

  up to 72 hours

• Hoarseness

  up to 72 hours

Study Arms (3)

Continuous Perineural Catheter

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.

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

10 mL Liposomal Bupivacaine Single Shot

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

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

20 mL Liposomal Bupivacaine Single Shot

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

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

Interventions

Ultrasound DIAGNOSTIC_TEST

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

10 mL Liposomal Bupivacaine Single Shot; 20 mL Liposomal Bupivacaine Single Shot; Continuous Perineural Catheter

Ropivacaine DRUG

Local anesthetic (numbing drug)

Also known as: Naropin

Continuous Perineural Catheter

Bupivacaine DRUG

Local anesthetic (numbing drug)

Also known as: Liposomal bupivacaine, Exparel, Marcaine

10 mL Liposomal Bupivacaine Single Shot; 20 mL Liposomal Bupivacaine Single Shot

MediPines AGM100 Advanced Respiratory Monitoring System DEVICE

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Also known as: non-invasive respiratory monitor

10 mL Liposomal Bupivacaine Single Shot; 20 mL Liposomal Bupivacaine Single Shot; Continuous Perineural Catheter

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients ages 18-80 undergoing shoulder surgery per standard of care.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Shoulder Injuries; Rotator Cuff Injuries

Interventions

Ultrasonography; Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Rupture; Tendon Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Amanda Kumar, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

WIlliam M Bullock, MD, PhD

CONTACT

919-681-6437; william.bullock@duke.edu

Amanda Kumar, MD

CONTACT

919-681-6437; amanda.kumar@duke.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: December 24, 2019
• Study Start: October 12, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 1, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)