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Shoulder block study checks for breathing side effects

NCT ID NCT04209504

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study observes 60 adults having shoulder surgery to see how often a common nerve block (interscalene brachial plexus block) causes temporary paralysis of the diaphragm, the main breathing muscle. Participants are split into three groups receiving different types of local anesthetics. Researchers use ultrasound to check diaphragm movement right after surgery and for three days afterward. The goal is to understand which block method is safest for breathing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ropivacaine and bupivacaine (local anesthetics)
What this could lead to
If successful, this could help doctors choose the safest nerve block method for shoulder surgery, reducing breathing complications.
What could go wrong
This is a small, early observational study, not a treatment trial. Results may not apply to all patients, and the nerve block itself carries rare risks like nerve damage or allergic reaction.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2021

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients ages 18-80 undergoing shoulder surgery per standard of care.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

osteoarthritis Rotator Cuff Injuries rotator cuff syndrome Shoulder Injuries Shoulder Pain

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Rotator cuff arthropathy of left shoulder Rotator cuff arthropathy of right shoulder Rotator cuff injuries Rotator cuff repair Rotator cuff tears Shoulder arthritis Shoulder disease Shoulder injuries Shoulder pain Shoulder surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Duke University Hospital

    RECRUITING

    Durham, North Carolina, 27710, United States

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