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

Launched by DUKE UNIVERSITY · Dec 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a specific type of nerve block used during shoulder surgeries to see if it causes a condition called hemidiaphragmatic paralysis, which can affect breathing. The trial involves patients aged 18 to 80 who are having primary shoulder surgery, and they will be randomly placed into three different groups. Each group will receive a different type of pain relief method involving local anesthetics. The main goal is to check if patients experience any breathing difficulties the day after their surgery, using a special ultrasound technique.

To participate in this trial, patients must be English-speaking and have a good overall health status (classified as ASA 1-3). They should live within 25 miles of the trial site and must not have any serious health issues, such as severe lung disease or a history of drug addiction. Participants will be monitored closely, and they can expect regular assessments to ensure their safety and comfort throughout the study. This trial is currently recruiting participants, and it's a great opportunity for those looking to manage shoulder pain effectively while contributing to important medical research.

Gender

ALL

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.