Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-25 @ 5:36 PM
Study NCT ID:
NCT04209504
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2019-12-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020069', 'term': 'Shoulder Pain'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D018771', 'term': 'Arthralgia'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D012421', 'term': 'Rupture'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2019-12-20', 'studyFirstSubmitQcDate': '2019-12-23', 'lastUpdatePostDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemidiaphragmatic paralysis - ipsilateral - postoperative day (POD) 1', 'timeFrame': '24 hours', 'description': 'Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis POD1'}], 'secondaryOutcomes': [{'measure': 'Hemidiaphragmatic paralysis - ipsilateral - PACU, POD2, POD3', 'timeFrame': 'up to 72 hours', 'description': 'Ultrasound guided evaluation of ipsilateral hemidiaphragmatic paralysis in PACU, POD2, and POD 3'}, {'measure': 'Noninvasive pulmonary measures of gas exchange', 'timeFrame': 'up to 72 hours', 'description': 'Noninvasive pulmonary measures of gas exchange'}, {'measure': 'Pain scores', 'timeFrame': 'up to 72 hours', 'description': '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'}, {'measure': 'Opioid consumption', 'timeFrame': 'up to 72 hours', 'description': 'Opioid consumption in Oral Morphine Equivalents (OMEs) at PACU, POD1, POD2, POD3'}, {'measure': 'Hoarseness', 'timeFrame': 'up to 72 hours', 'description': 'Incidence of recurrent laryngeal nerve palsy (subjective)'}, {'measure': "Horner's Syndrome", 'timeFrame': 'up to 72 hours', 'description': "Incidence of Horner's Syndrome"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rotator Cuff Repair', 'Shoulder Surgery', 'Hemidiaphragmatic paralysis', 'Interscalene Block', 'Interscalene Catheter', 'Interscalene Liposomal Bupivacaine'], 'conditions': ['Shoulder Surgery', 'Shoulder Pain', 'Shoulder Injuries', 'Shoulder Arthritis', 'Shoulder Disease', 'Rotator Cuff Tears', 'Rotator Cuff Injuries', 'Rotator Cuff Arthropathy of Left Shoulder', 'Rotator Cuff Arthropathy of Right Shoulder', 'Rotator Cuff Repair']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ages 18-80 undergoing shoulder surgery per standard of care.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* English speaking 18-80 year old ASA 1-3 patients\n* Primary shoulder surgery\n* Must live within a 25 mile radius\n\nExclusion Criteria:\n\n* ASA 4 or 5\n* Revision shoulder surgery\n* Diagnosis of chronic pain\n* Daily chronic opioid use (over 3 months of continuous opioid use)\n* Inability to communicate pain scores or need for analgesia\n* Infection at the site of block placement\n* Age under 18 years old or greater than 80 years old\n* Pregnant women (as determined by point-of-care serum bHCG)\n* Intolerance/allergy to local anesthetics\n* Weight \\<50 kg\n* BMI \\> 40\n* severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease\n* Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.\n* Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.\n* 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."}, 'identificationModule': {'nctId': 'NCT04209504', 'briefTitle': 'Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block', 'orgStudyIdInfo': {'id': 'Pro00104053'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Continuous Perineural Catheter', 'description': '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.', 'interventionNames': ['Diagnostic Test: Ultrasound', 'Drug: Ropivacaine', 'Device: MediPines AGM100 Advanced Respiratory Monitoring System']}, {'label': '10 mL Liposomal Bupivacaine Single Shot', 'description': 'Placement of preoperative single shot using 10mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine', 'interventionNames': ['Diagnostic Test: Ultrasound', 'Drug: Bupivacaine', 'Device: MediPines AGM100 Advanced Respiratory Monitoring System']}, {'label': '20 mL Liposomal Bupivacaine Single Shot', 'description': 'Placement of preoperative single shot using 20mL liposomal bupivacaine (Exparel; n=20) plus 5 mL 0.5% bupivacaine', 'interventionNames': ['Diagnostic Test: Ultrasound', 'Drug: Bupivacaine', 'Device: MediPines AGM100 Advanced Respiratory Monitoring System']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'Ultrasound guided evaluation of diaphragm ipsilateral to the block side.', 'armGroupLabels': ['10 mL Liposomal Bupivacaine Single Shot', '20 mL Liposomal Bupivacaine Single Shot', 'Continuous Perineural Catheter']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Naropin'], 'description': 'Local anesthetic (numbing drug)', 'armGroupLabels': ['Continuous Perineural Catheter']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Liposomal bupivacaine', 'Exparel', 'Marcaine'], 'description': 'Local anesthetic (numbing drug)', 'armGroupLabels': ['10 mL Liposomal Bupivacaine Single Shot', '20 mL Liposomal Bupivacaine Single Shot']}, {'name': 'MediPines AGM100 Advanced Respiratory Monitoring System', 'type': 'DEVICE', 'otherNames': ['non-invasive respiratory monitor'], 'description': 'Non-invasive respiratory monitor to measure oxygenation and ventilation parameters', 'armGroupLabels': ['10 mL Liposomal Bupivacaine Single Shot', '20 mL Liposomal Bupivacaine Single Shot', 'Continuous Perineural Catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'William M Bullock, MD, PhD', 'role': 'CONTACT', 'email': 'william.bullock@duke.edu', 'phone': '919-681-6437'}, {'name': 'Amanda Kumar, MD', 'role': 'CONTACT', 'email': 'amanda.kumar@duke.edu', 'phone': '919-681-6437'}, {'name': 'Amanda Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'William M Bullock, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeff C Gadsden, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'WIlliam M Bullock, MD, PhD', 'role': 'CONTACT', 'email': 'william.bullock@duke.edu', 'phone': '919-681-6437'}, {'name': 'Amanda Kumar, MD', 'role': 'CONTACT', 'email': 'amanda.kumar@duke.edu', 'phone': '919-681-6437'}], 'overallOfficials': [{'name': 'Amanda Kumar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}