Actively Recruiting
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Led by Duke University · Updated on 2025-10-01
60
Participants Needed
1
Research Sites
254 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking adults aged 18 to 80 years
- Classified as American Society of Anesthesiologists (ASA) physical status 1 to 3
- Scheduled for primary shoulder surgery
- Living within 25 miles of the study center
You will not qualify if you...
- ASA physical status 4 or 5
- Undergoing revision shoulder surgery
- Diagnosed with chronic pain
- Daily chronic opioid use for more than 3 months
- Unable to communicate pain levels or analgesia needs
- Infection at the site of nerve block placement
- Age under 18 or over 80 years
- Pregnant women (confirmed by serum bHCG test)
- Allergy or intolerance to local anesthetics
- Weighing less than 50 kg
- Body mass index over 40
- Severe lung diseases such as chronic obstructive or restrictive lung disease
- Known or suspected addiction or abuse of drugs or alcohol in the past 2 years
- Uncontrolled psychiatric conditions that may affect study participation
- Any significant medical condition increasing surgical risk or complicating recovery, as judged by the investigator
AI-Screening
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Trial Site Locations
Total: 1 location
1
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
Research Team
W
WIlliam M Bullock, MD, PhD
CONTACT
A
Amanda Kumar, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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