Shoulder SurgeryNCT04209504
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
An observational study of Shoulder Surgery and Shoulder Pain, run by Duke University at 1 site in United States.
Trial summary
This prospective observational study aims to evaluate the incidence of hemidiaphragmatic paralysis in patients receiving interscalene brachial plexus nerve block with prolonged neural blockade. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Surgery, Shoulder Pain, Shoulder Injuries
- What is being tested?
- Ultrasound, Ropivacaine and Bupivacaine
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2021to 31 Aug 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients ages 18-80 undergoing shoulder surgery per standard of care.
Who may be able to join
- English speaking 18-80 year old ASA 1-3 patients
- Primary shoulder surgery
- Must live within a 25 mile radius
Who cannot join
- 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
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University Hospital
Durham, North Carolina, 27710
William M Bullock, MD, PhD, 919-681-6437, william.bullock@duke.edu
Amanda Kumar, MD, 919-681-6437, amanda.kumar@duke.edu
About this study
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.
Read the detailed description
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 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 group 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. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.
- Conditions
- Shoulder Surgery, Shoulder Pain, Shoulder Injuries, Shoulder Arthritis, Shoulder Disease, Rotator Cuff Tears
- Being tested
- Ultrasound, Ropivacaine, Bupivacaine, MediPines AGM100 Advanced Respiratory Monitoring System
- Keywords
- Rotator Cuff Repair, Shoulder Surgery, Hemidiaphragmatic paralysis, Interscalene Block, Interscalene Catheter, Interscalene Liposomal Bupivacaine
- Medical subject headings
- Shoulder Pain, Shoulder Injuries, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
RopivacaineDrug
Also called Naropin
Local anesthetic (numbing drug)
BupivacaineDrug
Also called Liposomal bupivacaine, Exparel, Marcaine
Local anesthetic (numbing drug)
MediPines AGM100 Advanced Respiratory Monitoring SystemDevice
Also called non-invasive respiratory monitor
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
| Study group | Role | What they receive |
|---|---|---|
| Continuous Perineural Catheter | Placement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion. Receives: Diagnostic Test: Ultrasound; Drug: Ropivacaine; Device: MediPines AGM100 Advanced Respiratory Monitoring System | |
| 10 mL Liposomal Bupivacaine Single Shot | Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine Receives: Diagnostic Test: Ultrasound; Drug: Bupivacaine; Device: MediPines AGM100 Advanced Respiratory Monitoring System | |
| 20 mL Liposomal Bupivacaine Single Shot | Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine Receives: Diagnostic Test: Ultrasound; Drug: Bupivacaine; Device: MediPines AGM100 Advanced Respiratory Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1
Measured: 24 hours
Secondary outcomes (6)
Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3
Measured: up to 72 hours
Noninvasive pulmonary measures of gas exchange
Noninvasive pulmonary measures of gas exchange
Measured: up to 72 hours
Pain scores
Numerical Rating Scale (NRS) 11 pain scores (0-10; 0=no pain, 10=worst pain ever) at Post Anesthesia Care Unit (PACU), POD1, POD2, POD3
Measured: up to 72 hours
Opioid consumption
Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3
Measured: up to 72 hours
Hoarseness
Incidence of recurrent laryngeal nerve palsy (subjective)
Measured: up to 72 hours
Horner's Syndrome
Incidence of Horner's Syndrome
Measured: up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start12 Oct 2021
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder SurgeryStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amanda Kumar, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209504
- Sponsor's protocol ID
- Pro00104053
- Status last verified
- Oct 2026
- First submitted
- 20 Dec 2019
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used once patient has completed the study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT04209504
- Acronym / sponsor ID
- Pro00104053
- Conditions
- Shoulder Surgery, Shoulder Pain, Shoulder Injuries, Shoulder Arthritis, Shoulder Disease, Rotator Cuff Tears
- Keywords
- Rotator Cuff Repair, Shoulder Surgery, Hemidiaphragmatic paralysis, Interscalene Block, Interscalene Catheter, Interscalene Liposomal Bupivacaine
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 12 Oct 2021 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 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 group 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. Secondary outcomes include incidence of hemidiaphragmatic paralysis as measured by point of care ultrasound (POCUS) in the immediate postoperative period, postoperative day (POD) 1, POD2, and POD3 and noninvasive measures of pulmonary gas exchange at pre-op, post-op, POD1, POD2, and POD3. Additionally, the investigators will look at pain scores (scale of 0-10) and opioid consumption (in oral morphine equivalents) at previously defined time points listed above. Furthermore, the investigators will record known side effects of interscalene blocks including hoarseness and Horner's syndrome.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Continuous Perineural Catheter | – | Diagnostic Test: Ultrasound, Drug: Ropivacaine, Device: MediPines AGM100 Advanced Respiratory Monitoring SystemPlacement of preoperative continuous perineural catheter using 25 milliliters (mL) 0.5% ropivacaine with 1:400,000k ropivacaine for initial block and 0.2% ropivacaine for continuous infusion. |
| 10 mL Liposomal Bupivacaine Single Shot | – | Diagnostic Test: Ultrasound, Drug: Bupivacaine, Device: MediPines AGM100 Advanced Respiratory Monitoring SystemPlacement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine |
| 20 mL Liposomal Bupivacaine Single Shot | – | Diagnostic Test: Ultrasound, Drug: Bupivacaine, Device: MediPines AGM100 Advanced Respiratory Monitoring SystemPlacement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients ages 18-80 undergoing shoulder surgery per standard of care.
Key inclusion criteria (3 listed)
- English speaking 18-80 year old ASA 1-3 patients
- Primary shoulder surgery
- Must live within a 25 mile radius
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound guided evaluation of diaphragm ipsilateral to the block side. | Diagnostic test | 10 mL Liposomal Bupivacaine Single Shot, 20 mL Liposomal Bupivacaine Single Shot, Continuous Perineural Catheter |
| RopivacaineAlso: NaropinLocal anesthetic (numbing drug) | Drug | Continuous Perineural Catheter |
| BupivacaineAlso: Liposomal bupivacaine, Exparel, MarcaineLocal anesthetic (numbing drug) | Drug | 10 mL Liposomal Bupivacaine Single Shot, 20 mL Liposomal Bupivacaine Single Shot |
| MediPines AGM100 Advanced Respiratory Monitoring SystemAlso: non-invasive respiratory monitorNon-invasive respiratory monitor to measure oxygenation and ventilation parameters | Device | 10 mL Liposomal Bupivacaine Single Shot, 20 mL Liposomal Bupivacaine Single Shot, Continuous Perineural Catheter |
Primary outcome
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1
Time frame: 24 hours
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1
6 secondary outcomes
Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3
Time frame: up to 72 hours
Noninvasive pulmonary measures of gas exchange
Time frame: up to 72 hours
Pain scores
Time frame: up to 72 hours
Opioid consumption
Time frame: up to 72 hours
Hoarseness
Time frame: up to 72 hours
Horner's Syndrome
Time frame: up to 72 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared; patients will be deidentified and no personal information or medical records used once patient has completed the study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amanda Kumar, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Surgery and Shoulder Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WIlliam M Bullock, MD, PhD (919-681-6437, william.bullock@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1 (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.