Evaluating hemidiaphragmatic paralysis after shoulder surgery with nerve blocks

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to assess the incidence of hemidiaphragmatic paralysis in patients undergoing shoulder surgery who receive an interscalene brachial plexus nerve block with prolonged neural blockade. Participants, aged 18-80 and classified as ASA 1-3, will be randomized into three groups receiving different formulations of local anesthetics. The primary outcome will be measured using point of care ultrasound on postoperative day 1, with secondary outcomes including pain scores and opioid consumption monitored over several days. The study will also document known side effects associated with interscalene blocks.

Why it matters

Who can join: the full rules

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.

Where it's running

• Duke University Hospital
  Durham, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Amanda Kumar, MD — Duke University
• Study coordinator: WIlliam M Bullock, MD, PhD
• Email: william.bullock@duke.edu
• Phone: 919-681-6437

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.