Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-01-12 @ 10:06 PM
Study NCT ID:
NCT02180893
Status:
COMPLETED
Last Update Posted:
2016-03-15
First Post:
2014-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
The Use of Paravertebral Block for Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008944', 'term': 'Mitral Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Peter.Neuburger@nyumc.org', 'phone': '212 263 5821', 'title': 'Peter Neuberger', 'organization': 'NYU Langone Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valce surgery\n\nParavertebral Block: Paravertebral nerve block injection', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB', 'otherNumAtRisk': 30, 'otherNumAffected': 0, 'seriousNumAtRisk': 30, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Postoperative Fentanyl', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valve surgery\n\nParavertebral Block: Paravertebral nerve block injection'}, {'id': 'OG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB'}], 'classes': [{'categories': [{'measurements': [{'value': '4.51', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '6.14', 'spread': '2.88', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'unitOfMeasure': 'microgram/kilogram', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valve surgery\n\nParavertebral Block: Paravertebral nerve block injection'}, {'id': 'OG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB'}], 'classes': [{'categories': [{'measurements': [{'value': '3.33', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '4.13', 'spread': '1.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours', 'description': 'Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valve surgery\n\nParavertebral Block: Paravertebral nerve block injection'}, {'id': 'OG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}, {'value': '86.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '48 hours', 'description': 'Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)', 'unitOfMeasure': 'percentage of "yes" responders', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participant Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valve surgery\n\nParavertebral Block: Paravertebral nerve block injection'}, {'id': 'OG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB'}], 'classes': [{'categories': [{'measurements': [{'value': '8.44', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '6.83', 'spread': '1.90', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valce surgery\n\nParavertebral Block: Paravertebral nerve block injection'}, {'id': 'FG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}, {'groupId': 'FG001', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '23'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Paravertebral Block', 'description': 'Patient receiving a PVB prior to robotic mitral valce surgery\n\nParavertebral Block: Paravertebral nerve block injection'}, {'id': 'BG001', 'title': 'No Block', 'description': 'Patients who did not receive PVB\n\nPlacebo Comparator: No block\n\nPatients who did not receive PVB'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '60.1', 'spread': '12.2', 'groupId': 'BG000'}, {'value': '62.2', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '61.15', 'spread': '12.05', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-16', 'studyFirstSubmitDate': '2014-07-01', 'resultsFirstSubmitDate': '2016-02-16', 'studyFirstSubmitQcDate': '2014-07-02', 'lastUpdatePostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-02-16', 'studyFirstPostDateStruct': {'date': '2014-07-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Fentanyl', 'timeFrame': '24 hours'}, {'measure': 'Visual Analog Scale (VAS) Pain Scores', 'timeFrame': '24 hours', 'description': 'Possible scores range from 0-10, with 0 being no pain and 10 being highest level of pain'}], 'secondaryOutcomes': [{'measure': 'Participant Satisfaction', 'timeFrame': '48 hours', 'description': 'Participants were asked whether or not they were satisfied with their postoperative pain control (yes or no)'}, {'measure': 'Participant Satisfaction Score', 'timeFrame': '48 hours', 'description': 'Participants were asked to score their satisfaction with their postoperative pain control on a scale of 0 (least satisfied) to 10 (most satisfied)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Mitral Valve Insufficiency']}, 'referencesModule': {'references': [{'pmid': '22364970', 'type': 'BACKGROUND', 'citation': 'Suri RM, Antiel RM, Burkhart HM, Huebner M, Li Z, Eton DT, Topilsky T, Sarano ME, Schaff HV. Quality of life after early mitral valve repair using conventional and robotic approaches. Ann Thorac Surg. 2012 Mar;93(3):761-9. doi: 10.1016/j.athoracsur.2011.11.062.'}, {'pmid': '20472625', 'type': 'BACKGROUND', 'citation': 'Lynch JJ, Mauermann WJ, Pulido JN, Rehfeldt KH, Torres NE. Use of paravertebral blockade to facilitate early extubation after minimally invasive cardiac surgery. Semin Cardiothorac Vasc Anesth. 2010 Mar;14(1):47-8. doi: 10.1177/1089253210363009.'}]}, 'descriptionModule': {'briefSummary': 'Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently the investigators routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). The investigators believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.', 'detailedDescription': 'Pain after robotic cardiac surgery is a known problem and is often difficult to manage. Paravertebral nerve blocks are a proven method of pain relief following thoracotomy. A paravertebral block has been shown to provide good pain relief with minimal side effects, however, paravertebral blocks for robotic surgery have not been well studied. Currently we routinely perform PVB on this patient population (of 50 MV robotic cases done between January and October 2012, 36 received paravertebral blocks with no adverse events noted). We believe this should be studied further and that paravertebral blocks will reduce the amount of additional pain medication patients require in the first 24 hours after surgery, decrease intubation time and improve PACU and hospital discharge times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over the age of 18 years of age undergoing robotic mitral valve surgery.\n* have capacity to understand and sign consent form\n\nExclusion Criteria:\n\n* patients that are not candidates for paravertebral block as per ASRA guidelines (Horlocker, Reg Anesth Pain Med, 2010). In short, this includes patients taking specific anti platelet agents such as clopidigrel, anticoagulants such as heparin or low molecular weight heparin, or patients with an INR of greater than 1.5. -patients with a history of COPD or other respiratory diseases that would confound data on time to extubated will be excluded.\n* Patients that with a diagnosis of chronic pain, or patients currently taking narcotics are excluded, as this would confound data on postoperative narcotic requirements.'}, 'identificationModule': {'nctId': 'NCT02180893', 'briefTitle': 'The Use of Paravertebral Block for Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Study of Paravertebral Block for Cardiac Surgery', 'orgStudyIdInfo': {'id': 'S12-02774'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paravertebral block', 'description': 'Patient receiving a PVB prior to robotic mitral valve surgery', 'interventionNames': ['Other: Paravertebral Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'No block', 'description': 'Patients who did not receive PVB', 'interventionNames': ['Other: Placebo Comparator']}], 'interventions': [{'name': 'Paravertebral Block', 'type': 'OTHER', 'description': 'Paravertebral nerve block injection', 'armGroupLabels': ['Paravertebral block']}, {'name': 'Placebo Comparator', 'type': 'OTHER', 'description': 'No block\n\nPatients who did not receive PVB', 'armGroupLabels': ['No block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Peter J Neuburger, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}