Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-02-26 @ 2:14 AM
Study NCT ID:
NCT05919732
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2023-06-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Awake Caudal Catheter vs General Anesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D020927', 'term': 'Dexmedetomidine'}, {'id': 'D002110', 'term': 'Caffeine'}, {'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077123', 'term': 'Rocuronium'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D000732', 'term': 'Androstanols'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'gohalem.felema@nemours.org', 'phone': '904-416-5430', 'title': 'Dr. Gohalem Felema', 'organization': 'Nemours'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Within 24 hours post-operative', 'eventGroups': [{'id': 'EG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg', 'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 0, 'seriousNumAtRisk': 11, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Return to Baseline Respiratory Function.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 hours post operative', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Surgical Completion.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 24 hours', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Apneic Episodes.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '1.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post operative', 'description': 'Cessation of breathing by a premature infant that lasts for more than 20 seconds and/or is accompanied by hypoxia or bradycardia.', 'unitOfMeasure': 'Episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Number of Bradycardia Events.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post operative', 'description': 'heart rate \\<90.', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Days to Hospital Discharge From Surgery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'spread': '2', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 10 days', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Episodes Requiring Post-operative Narcotics Usage.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post operative', 'unitOfMeasure': 'episodes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Operative Time.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '28', 'groupId': 'OG000'}, {'value': '53', 'spread': '33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intraoperative, up to 100 minutes.', 'unitOfMeasure': 'Minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Participants Requiring Mechanical Ventilation.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'After 24 hours post operative', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Returning to Full Feeds.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'OG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 24 hours post operative', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'FG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.\n\nBupivacaine, Dexmedetomidine, Caffeine, Tylenol: bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg'}, {'id': 'BG001', 'title': 'General Anesthesia', 'description': 'General anesthesia and single-dose caudal injection\n\nPropofol, rocuronium, caffeine, Tylenol, bupivacaine: propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Gestational age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '28.4', 'spread': '3.3', 'groupId': 'BG000'}, {'value': '30.0', 'spread': '4.6', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '1.0', 'groupId': 'BG000'}, {'value': '3.1', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-09-22', 'size': 164390, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-28T10:49', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'The statistician for the study will generate a randomization table. An unblinded research coordinator will prepare randomization envelopes which will be numbered sequentially and placed in a bin located in the secure medication room in the peri-operative suite.Intra-operatively, neither the anesthesiologist nor the surgeon will be blinded since they are present from the induction of anesthesia until the conclusion of the operation for patient safety. The doctors, nurses and others caring for the infant postoperatively will be blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'A prospective, blinded, randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-04', 'studyFirstSubmitDate': '2023-06-16', 'resultsFirstSubmitDate': '2023-12-18', 'studyFirstSubmitQcDate': '2023-06-16', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-04', 'studyFirstPostDateStruct': {'date': '2023-06-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Return to Baseline Respiratory Function.', 'timeFrame': 'Within 24 hours post operative'}, {'measure': 'Surgical Completion.', 'timeFrame': 'Within 24 hours'}, {'measure': 'Number of Apneic Episodes.', 'timeFrame': '24 hours post operative', 'description': 'Cessation of breathing by a premature infant that lasts for more than 20 seconds and/or is accompanied by hypoxia or bradycardia.'}, {'measure': 'Number of Bradycardia Events.', 'timeFrame': '24 hours post operative', 'description': 'heart rate \\<90.'}], 'secondaryOutcomes': [{'measure': 'Days to Hospital Discharge From Surgery', 'timeFrame': 'up to 10 days'}, {'measure': 'Number of Episodes Requiring Post-operative Narcotics Usage.', 'timeFrame': '24 hours post operative'}, {'measure': 'Operative Time.', 'timeFrame': 'Intraoperative, up to 100 minutes.'}, {'measure': 'Participants Requiring Mechanical Ventilation.', 'timeFrame': 'After 24 hours post operative'}, {'measure': 'Number of Participants Returning to Full Feeds.', 'timeFrame': 'Within 24 hours post operative'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'It is well established that preterm inguinal hernias discovered in the NICU pose a significant surgical risk due to the associated co-morbid conditions that accompany these patients. Currently, the standard of care in the United States is general anesthesia. There have been studies that have established that elective outpatient repair of inguinal hernias found in the NICU can be safely performed. Patients that are ready for discharge from the NICU will have inguinal hernia repair prior to leaving. Inguinal hernia repair will also be done on those premature infants that are seen in the Nemours surgical clinic. Spinal anesthesia is currently the most common anesthetic procedure used in the surgical treatment of preterm inguinal hernias after general anesthesia. Caudal catheter technique has been proven to safely provide post-operative care of premature infants. The caudal catheter technique involves placement of a small catheter under ultrasound guidance into the caudal epidural canal to allow re-dosing of local anesthetic during the case and has been shown to be safe and effective management in neonates (Somri M, 2007).', 'detailedDescription': 'This is a prospective, blinded, randomized controlled trial evaluating the effectiveness of awake caudal catheter infusion versus single dose caudal injection and general anesthesia in the surgical management of preterm infant inguinal hernia repair. Spinal anesthesia has been advocated for but highly rejected in the pediatric surgical community due to its high failure rate, which can be up to 28%. Spinal anesthesia is a form of regional anesthesia involving injection of a local anesthetic into the subarachnoid space, via a fine needle, in a single injection. The failure rate has to do with the time constraint of spinal anesthesia, which is approximately 1 hour. It is difficult to perform a bilateral inguinal hernia in that time duration, necessitating a return trip to the operating room for the contralateral side or intubation midway through the surgical case. An alternative to spinal anesthesia that results in an ability to sustain regional anesthetic effect for a longer duration is the caudal catheter infusion. We hypothesize that awake caudal catheter infusion will allow for the following benefits (1) greater than 2 hour anesthetic time via re-dosing which will allow for the completion of the planned surgical procedure (2) exhibit a negligible failure rate (3) minimize post-operative complications that have been associated with general anesthesia in the preterm neonate.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Weeks', 'minimumAge': '23 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants less than 60 weeks post gestational age born at less than 37 weeks gestational age.\n* Patients in the NICU will meet discharge criteria with or without supplemental oxygen prior to surgical scheduling for inguinal hernia repair.\n\nExclusion Criteria:\n\n* Patient undergoing other invasive procedures (i.e. gastrostomy tube placement, tracheostomy, laser eye treatment)\n* Medical condition that would prevent a regional anesthetic from being performed (i.e. bleeding diathesis, vertebral anomalies, and spinal cord injury prior to surgery)\n* Contradictions to the prescribed medications in the protocol.'}, 'identificationModule': {'nctId': 'NCT05919732', 'briefTitle': 'Awake Caudal Catheter vs General Anesthesia', 'organization': {'class': 'OTHER', 'fullName': "Nemours Children's Clinic"}, 'officialTitle': 'Awake Caudal Catheter Infusion Versus General Anesthesia and Single-dose Caudal Injection for Preterm Neonatal Intensive Care Unit (NICU) Patients Undergoing Inguinal Herniorrhaphy.', 'orgStudyIdInfo': {'id': '16-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Caudal Infusion', 'description': 'Awake continuous caudal infusion.', 'interventionNames': ['Drug: Bupivacaine, Dexmedetomidine, Caffeine, Tylenol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'General anesthesia', 'description': 'General anesthesia and single-dose caudal injection', 'interventionNames': ['Drug: Propofol, rocuronium, caffeine, Tylenol, bupivacaine']}], 'interventions': [{'name': 'Bupivacaine, Dexmedetomidine, Caffeine, Tylenol', 'type': 'DRUG', 'description': 'bupivacaine .3% + 1: 200,000 epinephrine (dose 3mg/kg). Dexmedetomidine 0.5mcg/kg, Caffeine 15mg/kg, rectal Tylenol 30mg/kg', 'armGroupLabels': ['Caudal Infusion']}, {'name': 'Propofol, rocuronium, caffeine, Tylenol, bupivacaine', 'type': 'DRUG', 'description': 'propofol 3mg/kg and rocuronium 0.6mg/kg. Caffeine 15mg/kg and rectal Tylenol 30mg/kg.\n\nsingle shot caudal with bupivacaine 0.25% + 1:200,000 epinephrine (total dose 2.5mg/kg)', 'armGroupLabels': ['General anesthesia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32207', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "Nemours Children's Clinic", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Robert B Bryskin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Nemours Children's Clinic"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Nemours Children's Clinic", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist', 'investigatorFullName': 'Gohalem Felema', 'investigatorAffiliation': "Nemours Children's Clinic"}}}}