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

January 26, 2024 updated by: Duke University
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.

Study Overview

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 Type

Observational

Enrollment (Estimated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda Kumar, MD
        • Sub-Investigator:
          • William M Bullock, MD, PhD
        • Sub-Investigator:
          • Jeff C Gadsden, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Local anesthetic (numbing drug)
Other Names:
  • Naropin
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
Other Names:
  • non-invasive respiratory monitor
10 mL Liposomal Bupivacaine Single Shot
Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
Other Names:
  • non-invasive respiratory monitor
Local anesthetic (numbing drug)
Other Names:
  • Marcaine
  • Exparel
  • Liposomal 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
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
Other Names:
  • non-invasive respiratory monitor
Local anesthetic (numbing drug)
Other Names:
  • Marcaine
  • Exparel
  • Liposomal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1
Time Frame: 24 hours
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1
24 hours

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Amanda Kumar, MD, Duke University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2021

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

December 20, 2019

First Submitted That Met QC Criteria

December 23, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 26, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used once patient has completed the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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