RecruitingNCT04209504

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

Sponsor

Duke University

Enrollment

60 participants

Start Date

Oct 12, 2021

Study Type

OBSERVATIONAL

Conditions

Rotator Cuff Repair Shoulder Pain Rotator Cuff Tears Shoulder Injuries Shoulder Arthritis Shoulder Surgery Shoulder Disease Rotator Cuff Arthropathy of Left Shoulder Rotator Cuff Arthropathy of Right Shoulder rotator cuff injuries

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

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a prolonged nerve block technique for shoulder surgery that aims to provide pain relief for an extended period after the procedure. Standard nerve blocks for shoulder surgery (interscalene brachial plexus blocks) typically last 12–18 hours, but pain often returns before patients can get ahead of it with oral medications. This study is testing whether a longer-lasting nerve block can improve pain control and patient outcomes during early recovery. One known side effect of this type of nerve block is temporary paralysis of the diaphragm on the same side, which can affect breathing. The study will monitor how often this occurs and whether it causes any breathing difficulty. You may be eligible if: - You are between 18 and 80 years old - You speak English - You are having primary (first-time) shoulder surgery - You live within 25 miles of the hospital - You are ASA physical status 1, 2, or 3 You may NOT be eligible if: - You are having revision (repeat) shoulder surgery - You have chronic pain or use daily opioids - You are pregnant - You are allergic to local anesthetics - You have severe lung disease (COPD, restrictive lung disease) - Your BMI is over 40 or you weigh less than 50 kg Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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