- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04209504
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
January 26, 2024 updated by: Duke University
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.
Study Overview
Status
Recruiting
Conditions
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 Type
Observational
Enrollment (Estimated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: William M Bullock, MD, PhD
- Phone Number: 919-681-6437
- Email: william.bullock@duke.edu
Study Contact Backup
- Name: Amanda Kumar, MD
- Phone Number: 919-681-6437
- Email: amanda.kumar@duke.edu
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27710
- Recruiting
- Duke University Hospital
-
Contact:
- William M Bullock, MD, PhD
- Phone Number: 919-681-6437
- Email: william.bullock@duke.edu
-
Contact:
- Amanda Kumar, MD
- Phone Number: 919-681-6437
- Email: amanda.kumar@duke.edu
-
Principal Investigator:
- Amanda Kumar, MD
-
Sub-Investigator:
- William M Bullock, MD, PhD
-
Sub-Investigator:
- Jeff C Gadsden, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients ages 18-80 undergoing shoulder surgery per standard of care.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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.
|
Local anesthetic (numbing drug)
Other Names:
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
Other Names:
|
10 mL Liposomal Bupivacaine Single Shot
Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
|
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
Other Names:
Local anesthetic (numbing drug)
Other Names:
|
20 mL Liposomal Bupivacaine Single Shot
Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine
|
Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
Other Names:
Local anesthetic (numbing drug)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1
Time Frame: 24 hours
|
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3
Time Frame: up to 72 hours
|
Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3
|
up to 72 hours
|
Noninvasive pulmonary measures of gas exchange
Time Frame: up to 72 hours
|
Noninvasive pulmonary measures of gas exchange
|
up to 72 hours
|
Pain scores
Time Frame: up to 72 hours
|
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
|
up to 72 hours
|
Opioid consumption
Time Frame: up to 72 hours
|
Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3
|
up to 72 hours
|
Hoarseness
Time Frame: up to 72 hours
|
Incidence of recurrent laryngeal nerve palsy (subjective)
|
up to 72 hours
|
Horner's Syndrome
Time Frame: up to 72 hours
|
Incidence of Horner's Syndrome
|
up to 72 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Amanda Kumar, MD, Duke University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 12, 2021
Primary Completion (Estimated)
August 31, 2025
Study Completion (Estimated)
August 31, 2025
Study Registration Dates
First Submitted
December 20, 2019
First Submitted That Met QC Criteria
December 23, 2019
First Posted (Actual)
December 24, 2019
Study Record Updates
Last Update Posted (Estimated)
January 29, 2024
Last Update Submitted That Met QC Criteria
January 26, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Pain
- Neurologic Manifestations
- Musculoskeletal Diseases
- Rupture
- Tendon Injuries
- Arthralgia
- Rotator Cuff Injuries
- Wounds and Injuries
- Joint Diseases
- Shoulder Pain
- Paralysis
- Shoulder Injuries
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Anesthetics, Local
- Bupivacaine
- Ropivacaine
Other Study ID Numbers
- Pro00104053
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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