Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT06958120
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-13
First Post:
2025-04-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-10', 'studyFirstSubmitDate': '2025-04-25', 'studyFirstSubmitQcDate': '2025-05-03', 'lastUpdatePostDateStruct': {'date': '2025-05-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain assessment', 'timeFrame': 'Immediately after admission to ICU then at 60 min, 2 hours, 4 hours, 8 hours and 12 hours postoperatively', 'description': 'Pain was assessed by the pediatric observational 10-point scale "Face, Leg, Activity, Cry, Consolability (FLACC) pain score.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CHD', 'Regional anaesthesia', 'Pain management'], 'conditions': ['CHD - Congenital Heart Disease']}, 'descriptionModule': {'briefSummary': 'Group (A): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side3.\n\nGroup (B): This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral ESPB which will be done by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) at each side .', 'detailedDescription': 'Preoperative assessment Premedication Monitoring General Anesthesia induction Arterial and Venous cannulation Fentanyl Infusion Giving block according to the group Intra operative recording of hemodynamics Post operative pain assessment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '4 Years', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RACHS-1: Categories 1, 2 and 3\n* Patients undergoing corrective cardiac surgeries with midline sternotomy incision.\n* Redo surgeries.\n\nExclusion Criteria:\n\n* Patients whose parents or legal guardians refuse to participate.\n* Preoperative mechanical ventilation.\n* Preoperative inotropic drug infusion.\n* Coagulopathy.\n* Allergy to any of the studied drugs.\n* Severe pulmonary hypertension (\\> 70 mmHg).'}, 'identificationModule': {'nctId': 'NCT06958120', 'briefTitle': 'Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Analgesic Efficacy of Bilateral Ultrasound Guided Superficial Parasternal Intercostal Plane Block Versus Erector Spinae Plane Block in Pediatric Patients Undergoing Corrective Cardiac Surgeries - A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'BLocks in pediatric cardiac op'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Superficial parasternal intercostal Plane block group', 'description': 'This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus ultrasound guided bilateral superficial parasternal intercostal Plane block', 'interventionNames': ['Procedure: superficial parasternal intercostal Plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Erecto-Spinea plane block group', 'description': 'This group will receive fentanyl infusion at a dose of (0.5μg/kg/h) all through the whole operation plus Ultrasound guided bilateral Erecto-Spinea plane block', 'interventionNames': ['Procedure: Erecto spinea plane block']}], 'interventions': [{'name': 'superficial parasternal intercostal Plane block', 'type': 'PROCEDURE', 'description': 'A high-frequency linear transducer was used to guide the insertion of a needle 2 cm lateral to the sternum. After identifying key anatomical structures, the needle was advanced in-plane into the pectointercostal fascial plane between the pectoralis major and internal intercostal muscle. Correct placement was confirmed with a saline injection, and then a local anesthetic (0.4 ml/kg of a 1:1 mix of bupivacaine 0.25% and lidocaine 1%) was injected bilaterally at the second and fourth ribs.', 'armGroupLabels': ['Superficial parasternal intercostal Plane block group']}, {'name': 'Erecto spinea plane block', 'type': 'PROCEDURE', 'description': 'Using ultrasound, a needle is inserted near the T5 vertebra into the plane beneath the erector spinae muscle. After confirming correct positioning with saline, a local anesthetic mixture is injected in the fascial plane.', 'armGroupLabels': ['Erecto-Spinea plane block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'contacts': [{'name': 'Cairo University hospitals', 'role': 'CONTACT', 'email': 'website@kasralainy.edu.eg', 'phone': '+20223643524'}], 'facility': 'Abu Al reesh hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': '2026', 'ipdSharing': 'YES', 'description': 'yes', 'accessCriteria': 'Any'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant professor', 'investigatorFullName': 'Reham Mahrous', 'investigatorAffiliation': 'Cairo University'}}}}