Ignite Creation Date:
2025-12-17 @ 1:44 PM
Ignite Modification Date:
2025-12-23 @ 10:23 PM
Study NCT ID:
NCT02512861
Status:
COMPLETED
Last Update Posted:
2018-08-22
First Post:
2014-06-06
Is Possible Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-22'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mark.logalbo@childrensmn.org', 'phone': '(612)-813-7828', 'title': 'Mark Lo Galbo, MPH, CCRP', 'organization': "Children's Hospitals and Clinics of Minnesota"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data was collected over the first five post-operative days.', 'description': 'The method for collecting adverse event information was via daily collection form/questionnaire by the study coordinator for the first five post-operative days.', 'eventGroups': [{'id': 'EG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 0, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'seriousEvents': [{'term': 'Shallow Breathing/Increased Work of Breathing', 'notes': 'Patient required either non-invasive respiratory support or reintubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Significant blood/chest tube losses requiring transfusion or fluid resuscitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumothorax or Pleural effusion', 'notes': 'Patient required reinitiation of chest tubes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute respiratory syncytial virus leading to pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Fentanyl/Equivalent Day 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '23.6', 'groupId': 'OG000', 'lowerLimit': '10.7', 'upperLimit': '34.3'}, {'value': '22.4', 'groupId': 'OG001', 'lowerLimit': '13.3', 'upperLimit': '32.6'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of Surgery and Postoperative Day 1', 'unitOfMeasure': 'mcg/kg/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '15.7', 'groupId': 'OG000', 'lowerLimit': '8.5', 'upperLimit': '22.1'}, {'value': '14.6', 'groupId': 'OG001', 'lowerLimit': '10.6', 'upperLimit': '21.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of Surgery and Postoperative Day 1', 'unitOfMeasure': 'mcg/kg/day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Length of Intubation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000', 'lowerLimit': '3.7', 'upperLimit': '19.5'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '3.3', 'upperLimit': '22.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '5 days post cardiac surgery', 'unitOfMeasure': 'hours', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Cortisol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '25.4', 'groupId': 'OG000', 'lowerLimit': '15.5', 'upperLimit': '44.8'}, {'value': '27.7', 'groupId': 'OG001', 'lowerLimit': '14.9', 'upperLimit': '59.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '12 hours post-surgery', 'unitOfMeasure': 'microgram/deciliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2.88'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '1.15'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of Surgery', 'description': 'Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Pain Scores-State Behavioral Scale (SBS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.25', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '1'}, {'value': '-0.25', 'groupId': 'OG001', 'lowerLimit': '-1', 'upperLimit': '0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of Surgery', 'description': 'State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Postoperative Cortisol Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'classes': [{'categories': [{'measurements': [{'value': '9.4', 'groupId': 'OG000', 'lowerLimit': '5.1', 'upperLimit': '17.3'}, {'value': '9.1', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '20.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '36 hours post-surgery', 'unitOfMeasure': 'microgram/deciliter', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery\n\nBupivacaine: Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Normal Saline\n\nPlacebo: Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000', 'lowerLimit': '0.4', 'upperLimit': '3.3'}, {'value': '0.8', 'groupId': 'BG001', 'lowerLimit': '0.4', 'upperLimit': '3.7'}, {'value': '0.84', 'groupId': 'BG002', 'lowerLimit': '0', 'upperLimit': '3'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Black/African American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'White/Caucasian', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '56', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'American Indian/Alaskan', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Bi-racial', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Declined', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Comorbidities', 'classes': [{'categories': [{'title': 'Respiratory', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Gastrointestinal', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Genetic', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}, {'title': 'Neurodevelopmental/Developmental Delay', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'None', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Any additional medical conditions that the patient had in addition to the cardiac defect were collected and categorized into the following:\n\n1. Respiratory\n2. Gastrointestinal\n3. Genetic\n4. Neurodevelopmental/Developmental Delay\n5. Other', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2014-06-06', 'resultsFirstSubmitDate': '2018-01-24', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-20', 'studyFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Fentanyl/Equivalent Day 0-1', 'timeFrame': 'Day of Surgery and Postoperative Day 1'}, {'measure': 'Patient-Controlled Analgesia (PCA) Fentanyl/Equivalent Day 0-1', 'timeFrame': 'Day of Surgery and Postoperative Day 1'}], 'secondaryOutcomes': [{'measure': 'Postoperative Length of Intubation', 'timeFrame': '5 days post cardiac surgery'}, {'measure': 'Postoperative Cortisol Levels', 'timeFrame': '12 hours post-surgery'}, {'measure': 'Postoperative Pain Scores-Face, Legs, Activity, Cry, Consolability (FLACC) Scale', 'timeFrame': 'Day of Surgery', 'description': 'Face, Legs, Activity, Cry, Consolability (FLACC) scale: range is from 0 to 10 and a higher score indicates greater level of pain (worse outcome).'}, {'measure': 'Postoperative Pain Scores-State Behavioral Scale (SBS)', 'timeFrame': 'Day of Surgery', 'description': 'State Behavioral Scale (SBS): range is from -3 to 2. A higher score indicates a patient is more uncomfortable and agitated (worse outcome).'}, {'measure': 'Postoperative Cortisol Levels', 'timeFrame': '36 hours post-surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Bupivacaine', 'Cardiac Surgery', 'Pediatrics', 'Nerve Block'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. The investigators hypothesize that Bupivacaine, a parasternal nerve block administered in pediatric patients undergoing cardiac surgery will reduce the requirement of Opioids and other pain medications as well as decrease postoperative pain scores. This is a prospective, double-blind, randomized controlled trial. Subjects are randomized to receive either 0.25% Bupivacaine or normal saline following their cardiothoracic surgery.', 'detailedDescription': 'One of the most challenging struggles in clinical practices in pediatric cardiac intensive care units is the provision of optimal and safe postoperative analgesia and sedation. All pediatric patients who undergo cardiac surgery require analgesic medications for postoperative pain control and many require sedation to facilitate comfort with cares. Parasternal infiltration of local anesthetic for nerve blocks is a simple option to postoperative analgesia. Bupivacaine is a local anesthetic that can be injected into the intercostal spaces on each side of a sternotomy to induce nerve block.\n\nThe purpose of this study is to evaluate whether the use of Bupivacaine as a nerve block in children undergoing cardiothoracic surgery will reduce postoperative pain medication use and decrease postoperative pain scores. The investigators hypothesize that the administration of Bupivacaine bilaterally into the posterior intercostal spaces on each side of a sternotomy following cardiothoracic surgery will reduce the requirement of pain medications as well as decrease postoperative pain scores.\n\nThis is a prospective, randomized, double-blind, control study. Subjects are randomized into two arms: those who receive 0.25% Bupivacaine and those who receive placebo (normal saline). Subjects receive 1 milliliter per kilogram up to 20 kilograms, then 0.5 milliliters per kilogram up to 50 kilograms of study drug.\n\nSubjects are followed for 5 days postoperatively, then on day of discharge. Pain medication administered and Face, Legs, Activity, Cry, and Consolability (FLACC) scores are recorded daily for 5 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 0-17 years old at time of surgery\n* Society of Thoracic Surgeons- European Association for Cardio-Thoracic Surgery (STAT) mortality categories 1-3\n* Surgical intervention requiring median sternotomy\n* Expected extubation within 24 hours of surgery\n\nExclusion Criteria:\n\n* Known allergic reaction or hypersensitivity to Bupivacaine or to any local anesthetic agent of the amide type\n* Delayed sternum closure'}, 'identificationModule': {'nctId': 'NCT02512861', 'briefTitle': 'Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': "Children's Hospitals and Clinics of Minnesota"}, 'officialTitle': 'Parasternal Nerve Block Using Bupivacaine for Postoperative Analgesia in Children Undergoing Cardiac Surgery: A Prospective: Double-Blind, Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '1311-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': 'Bupivacaine as a parasternal nerve block following pediatric cardiothoracic surgery', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Normal Saline', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine', 'Sensorcaine'], 'description': 'Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients \\> 50 kgs', 'armGroupLabels': ['Bupivacaine']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Normal Saline'], 'description': 'Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:\n\nUnder 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients \\> 50 kgs', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Hospitals and Clinics of Minnesota", 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Francis X Moga, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Children's Hospitals and Clinics of Minnesota"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Hospitals and Clinics of Minnesota", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}