RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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 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.

Official Title

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

Quick Facts

Study Start:2021-10-12
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04209504

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.

Ages Eligible for Study:18 Years to 80 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * English speaking 18-80 year old ASA 1-3 patients
  2. * Primary shoulder surgery
  3. * Must live within a 25 mile radius
  1. * ASA 4 or 5
  2. * Revision shoulder surgery
  3. * Diagnosis of chronic pain
  4. * Daily chronic opioid use (over 3 months of continuous opioid use)
  5. * Inability to communicate pain scores or need for analgesia
  6. * Infection at the site of block placement
  7. * Age under 18 years old or greater than 80 years old
  8. * Pregnant women (as determined by point-of-care serum bHCG)
  9. * Intolerance/allergy to local anesthetics
  10. * Weight \<50 kg
  11. * BMI \> 40
  12. * severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
  13. * Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
  14. * Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
  15. * 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.

Contacts and Locations

Study Contact

WIlliam M Bullock, MD, PhD
CONTACT
919-681-6437
william.bullock@duke.edu
Amanda Kumar, MD
CONTACT
919-681-6437
amanda.kumar@duke.edu

Principal Investigator

Amanda Kumar, MD
PRINCIPAL_INVESTIGATOR
Duke University

Study Locations (Sites)

Duke University Hospital
Durham, North Carolina, 27710
United States

Collaborators and Investigators

Sponsor: Duke University

  • Amanda Kumar, MD, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2021-10-12
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-10-12
Study Completion Date2025-08-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • 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