No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 80
Sex
Any
Study type
Observational
Participants needed
60 (estimated)
Sponsor
Duke University · Other
Who this trial is looking for
This trial is looking for patients who need shoulder surgery and are between 18 and 80 years old. Participants will receive different types of nerve blocks to help manage pain after their surgery.
Are You a Good Fit for This Trial?
Rules you outChronic obstructive pulmonary diseaseRestrictive lung diseaseAddiction to drugs or alcoholUncontrolled anxietySchizophrenia
You may be able to join if
I am between 18 and 80 years old
I speak English
I need primary shoulder surgery
I live within 25 miles of the study site
You may not be able to join if
I have had revision shoulder surgery
I have chronic pain
I use opioids daily for more than 3 months
I cannot communicate my pain levels
I have an infection where the nerve block will be placed
I am pregnant
I am allergic to local anesthetics
I weigh less than 50 kg
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 cathete…
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.
Trial Locations
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Eligibility 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)
* Inab…
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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