Actively Recruiting

Age: 18Years - 80Years
All Genders
ID04209504

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

Led by Duke University · Updated on 2025-10-01

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the occurrence of hemidiaphragmatic paralysis in patients undergoing shoulder surgery who receive an interscalene brachial plexus nerve block with prolonged neural blockade. This observational study includes English-speaking patients aged 18 to 80 with ASA physical status 1 to 3. Participants are divided into three groups to compare different nerve block methods. The main goal is to assess diaphragm paralysis on the first day after surgery using ultrasound imaging. Participants are assigned to one of three treatment groups: one receives a continuous infusion of 0.2% ropivacaine through a perineural catheter; the second group receives a single injection of 10 mL liposomal bupivacaine plus 5 mL of 0.5% bupivacaine; the third group receives a single injection of 20 mL liposomal bupivacaine plus 5 mL of 0.5% bupivacaine. The exact dosing for the third group is determined by the attending anesthesiologist. The study uses ultrasound to monitor diaphragm function and a non-invasive respiratory monitor to evaluate lung function. During the study, participants are monitored using point-of-care ultrasound immediately after surgery and on postoperative days 1, 2, and 3 to detect diaphragm paralysis. Researchers also measure pulmonary gas exchange, pain levels on a 0-10 scale, opioid use, and side effects like hoarseness and Horner's syndrome during this 72-hour period. The study continues until August 2026, with all evaluations focused on the first three days after surgery to understand the safety and effects of these nerve block techniques.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • English speaking patients aged 18 to 80 years
  • ASA physical status classification 1 to 3
  • Scheduled for primary shoulder surgery
  • Must live within 25 miles of the study location
Not Eligible

You will not qualify if you...

  • ASA physical status classification 4 or 5
  • Undergoing revision shoulder surgery
  • Diagnosis of chronic pain
  • Daily chronic opioid use over 3 months
  • Unable to communicate pain or analgesia needs
  • Infection at the nerve block site
  • Pregnant women as determined by serum bHCG
  • Weight under 50 kg
  • Body mass index over 40
  • Severe pulmonary diseases such as COPD or restrictive lung disease
  • Known or suspected addiction to drugs, prescription medicines, or alcohol in past 2 years
  • Uncontrolled psychiatric disorders that may affect study compliance
  • Any clinically significant disease increasing surgery risk or complicating recovery as judged by investigator

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 days

Participants receive ultrasound and respiratory monitoring assessments before and after shoulder surgery to evaluate diaphragm function and pulmonary gas exchange.

Assessments at preoperative, immediate postoperative, and postoperative days 1, 2, and 3

Monitoring

Duration - Up to 3 days

Participants are observed for signs of hemidiaphragmatic paralysis, pain levels, opioid use, and side effects such as hoarseness and Horner's syndrome following nerve block administration.

Daily assessments for up to 3 days post-surgery

Trial Site Locations

Total: 1 location

1

Duke University Hospital

Durham, North Carolina, United States, 27710

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Research Team

W

WIlliam M Bullock, MD, PhD

A

Amanda Kumar, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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