Recruiting

Interscalene Block

Sponsor:

Duke University

Code:

NCT04209504

Conditions

Shoulder Surgery

Shoulder Pain

Shoulder Injuries

Shoulder Arthritis

Shoulder Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Ultrasound

Ropivacaine

Bupivacaine

MediPines AGM100 Advanced Respiratory Monitoring System

Study Details

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

Study ID

NCT04209504

Start date

Oct 12, 2021

Status verified date

Sep, 2025

Completion date

Aug 31, 2026

Anticipated

Primary completion date

Aug 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

10 mL Liposomal Bupivacaine Single Shot

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

20 mL Liposomal Bupivacaine Single Shot

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

Interventions

Ultrasound

Ultrasound guided evaluation of diaphragm ipsilateral to the block side.

Ropivacaine

Local anesthetic (numbing drug)

Bupivacaine

Local anesthetic (numbing drug)

MediPines AGM100 Advanced Respiratory Monitoring System

Non-invasive respiratory monitor to measure oxygenation and ventilation parameters

Primary outcome measure

  • Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 [ Time Frame: 24 hours ]

Central Contacts and Locations

Central contacts

WIlliam M Bullock, MD, PhD

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

Amanda Kumar, MD

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

Locations

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27710

Contacts

William M Bullock, MD, PhD

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

Amanda Kumar, MD

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

Principal Investigator:

Amanda Kumar, MD

More Information

Sponsor

Duke University

Last update posted

Oct 1, 2025

Last verified

Sep, 2025

Keywords

  • Rotator Cuff Repair
  • Shoulder Surgery
  • Hemidiaphragmatic paralysis
  • Interscalene Block
  • Interscalene Catheter
  • Interscalene Liposomal Bupivacaine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Duke University on 2025-10-01.