Ignite Creation Date:
2025-12-25 @ 3:03 AM
Ignite Modification Date:
2025-12-31 @ 11:58 AM
Study NCT ID:
NCT04918433
Status:
UNKNOWN
Last Update Posted:
2021-06-08
First Post:
2021-05-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Regional Anaesthetic Blocks for ERAS After Congenital Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-07-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-06', 'studyFirstSubmitDate': '2021-05-27', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight, height , BMI', 'timeFrame': '1 year', 'description': 'Weight in kg and height in cm to allow BMI measurement weight (kg) / height (m2)'}, {'measure': 'Postoperative pain score', 'timeFrame': '1 year', 'description': 'Postoperative pain score at rest, hemodynamic effects, analgesic consumption'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Local Infiltration']}, 'descriptionModule': {'briefSummary': 'The current study is designed to compare the perioperative analgesic efficacy of transversus thoracis plane block (TTPB) and Pecto-intercostal-fascial plane block (PIFB) in children undergoing cardiac surgery via median sternotomy', 'detailedDescription': 'Sixty paediatric patients of either sex, aged 2-12 years, undergoing elective cardiac surgery via median sternotomy. Patients will be excluded from the current study in case of, refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension, and when extubation is intentionally planned to be delayed. Patients will be randomly assigned to one of two equal groups, the PIF block group and TTP block group, each will include 30 patients, by a computer-generated randomization table and concealed sealed opaque envelopes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* either sex, aged 2-12 years, undergoing\n\nelective cardiac surgery via median sternotomy\n\nExclusion Criteria:\n\n* refusal to participate, redo or urgent cardiac surgery, local infection of the skin at the site of needle puncture, allergy to bupivacaine, coagulation disorders, clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension'}, 'identificationModule': {'nctId': 'NCT04918433', 'briefTitle': 'Comparison of Two Regional Anaesthetic Blocks for ERAS After Congenital Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Alexandria'}, 'officialTitle': 'Comparison of Pectointercostal Block and Transverse Thoracic Plane Block for ERAS Post Congenital Cardiac Surgery', 'orgStudyIdInfo': {'id': '118'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)', 'description': 'After induction of anaesthesia, ultrasound guided transverses thoracis muscle plane block will be done using 0.25% bupivacaine', 'interventionNames': ['Procedure: Regional anaesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)', 'description': 'After induction of anaesthesia, ultrasound guided pectointercostal facial plane block will be done using 0.25% bupivacaine', 'interventionNames': ['Procedure: Regional anaesthesia']}], 'interventions': [{'name': 'Regional anaesthesia', 'type': 'PROCEDURE', 'description': 'Regional anaesthesia for sternotomy incision for congenital cardiac surgery', 'armGroupLabels': ['PECTO-INTERCOSTAL FACIAL PLANE BLOCK (PIFB)', 'TRANSEVERSUS THORACIS MUSCLE PLANE BLOCK (TTPB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23541', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Nagwa Kobea, Phd', 'role': 'CONTACT', 'email': 'kobea@yahoo.com', 'phone': '+20 122 336 8233'}], 'facility': 'Alexandria university', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Ibrahim Mabrouk, Phd', 'role': 'CONTACT', 'email': 'ibrahim_wama@hotmail.com', 'phone': '00201224336786'}, {'name': 'Islam Elbardan, Phd', 'role': 'CONTACT', 'email': 'Islamelbardan@gmail.com', 'phone': '+20 111 227 8083'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alexandria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Ibrahim Mabrouk Ibrahim', 'investigatorAffiliation': 'University of Alexandria'}}}}