Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:03 AM
Study NCT ID:
NCT05153720
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2021-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-22', 'studyFirstSubmitDate': '2021-11-29', 'studyFirstSubmitQcDate': '2021-11-29', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'opioid consumption', 'timeFrame': 'First 24 hours postoperatively', 'description': 'postoperative morphine consumption'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia']}, 'descriptionModule': {'briefSummary': 'The study aim to compare ultrasound guided erector spinae plane block versus ultrasound guided caudal block in perioperative analgesia for pediatric cancer patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I and II\n* Age \\>1 and \\<12\n* patients undergoing nephrectomy surgeries\n\nExclusion Criteria:\n\n* patients parental refusal\n* local infection at the puncture site\n* coagulopathy with INR\\> 1.6\n* unstable cardiovascular disease\n* patients allergic to medication used\n* development or mental delay\n* impaired liver and renal functions'}, 'identificationModule': {'nctId': 'NCT05153720', 'briefTitle': 'Erector Spinae Block Versus Caudal Block for Perioperative Analgesia in Pediatric Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Comparison of Ultrasound Guided Erector Spinae Block and Ultrasound Guided Caudal for Perioperative Analgesia in Pediatric Cancer Patients Undergoing Nephrectomy Surgeries: a Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'AP2109-30109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound guided erector spinae plane block', 'description': 'Unilateral erector spinae plane block will be performed under ultrasound guidance', 'interventionNames': ['Procedure: Erector spinae plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ultrasound guided caudal block', 'description': 'Caudal block will be formed under ultrasound guidance', 'interventionNames': ['Procedure: Caudal block']}], 'interventions': [{'name': 'Erector spinae plane block', 'type': 'PROCEDURE', 'description': 'Ultrasound guided erector spinae plane block', 'armGroupLabels': ['Ultrasound guided erector spinae plane block']}, {'name': 'Caudal block', 'type': 'PROCEDURE', 'description': 'Ultrasound guided caudal block', 'armGroupLabels': ['Ultrasound guided caudal block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Walaa Y Elsabeeny', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Walaa Y Elsabeeny, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Anesthesia and Pain Management, National Cancer Institute, Cairo University'}, {'name': 'Yasmen F Abdelghani, M.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Lecturer of Anesthesia and Pain Management, National Cancer Institute, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesia and Pain management', 'investigatorFullName': 'Walaa Youssef Elsabeeny', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}