Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Recruiting now
Conditions studied: 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
In brief
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.
Key facts
- Study ID
- NCT04209504
- Run by
- Duke University
- People needed
- 60
- Starts
- 2021-10-12
- Expected to finish
- 2026-08-31
- Last updated by the study team
- 2025-10-01
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- English speaking 18-80 year old ASA 1-3 patients
- Primary shoulder surgery
- Must live within a 25 mile radius
You may not qualify if…
- 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.
Where it is running
- Duke University Hospital — Durham, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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