NCT04209504 Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
| NCT ID | NCT04209504 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Duke University |
| Condition | Shoulder Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-10-12 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2021-10-12 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Amanda Kumar, MD
PRINCIPAL INVESTIGATOR
Duke University
Frequently Asked Questions
Who can join the NCT04209504 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Shoulder Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04209504 currently recruiting?
Yes, NCT04209504 is actively recruiting participants. Contact the research team at william.bullock@duke.edu for enrollment information.
Where is the NCT04209504 trial being conducted?
This trial is being conducted at Durham, United States.
Who is sponsoring the NCT04209504 clinical trial?
NCT04209504 is sponsored by Duke University. The principal investigator is Amanda Kumar, MD at Duke University. The trial plans to enroll 60 participants.