Evaluating hemidiaphragmatic paralysis after shoulder surgery with nerve blocks
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
This study is testing how often patients having shoulder surgery with a specific nerve block experience breathing issues and how it affects their pain and use of pain medication afterward.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Duke University Academic / other |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT04209504 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients aged 18-80 with ASA physical status 1-3 undergoing primary shoulder surgery.
Not a fit: Patients with severe pulmonary disease, chronic pain, or those who are pregnant will likely not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve postoperative pain management and reduce the incidence of hemidiaphragmatic paralysis in shoulder surgery patients.
How similar studies have performed: Similar studies evaluating nerve blocks have shown promising results, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Durham, North Carolina
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.