Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-07 @ 6:02 AM
Study NCT ID:
NCT04690894
Status:
COMPLETED
Last Update Posted:
2021-03-08
First Post:
2020-12-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-12', 'releaseDate': '2021-03-17'}, {'resetDate': '2021-06-22', 'releaseDate': '2021-06-01'}, {'resetDate': '2021-08-12', 'releaseDate': '2021-07-19'}, {'resetDate': '2021-10-06', 'releaseDate': '2021-09-09'}], 'estimatedResultsFirstSubmitDate': '2021-03-17'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-04', 'studyFirstSubmitDate': '2020-12-28', 'studyFirstSubmitQcDate': '2020-12-28', 'lastUpdatePostDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients need rescue analgesia', 'timeFrame': '24 hours', 'description': 'total number of patients need addition of anagesia'}], 'secondaryOutcomes': [{'measure': 'First analgesic request', 'timeFrame': '24 hours', 'description': 'First time that patient require analgesia'}, {'measure': 'Hemodynamic changes in the study period', 'timeFrame': '24 hours', 'description': 'Changes in HR and blood pressure'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia']}, 'referencesModule': {'references': [{'pmid': '35793181', 'type': 'DERIVED', 'citation': 'Abdelrazik AN, Ibrahim IT, Farghaly AE, Mohamed SR. Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patients Undergoing Lower Abdominal Surgeries. Pain Physician. 2022 Jul;25(4):E571-E580.'}]}, 'descriptionModule': {'briefSummary': 'this prospective randomized double blind controlled study was conducted on 60 child scheduled for lower abdominal surgery under general anesthesia. the patients were randomly allocated into 3 parallel groups.group (ESB) patients received ultrasound-guided erector spinae block in a dose of 0.4mg/ml of 0.25%bupivacaine between the 10th transverse process and erector spinae muscles.group(CB) patients received ultrasound-guided caudal block in a dose of 2.5mg/kg of 0.25%bupivacaine. group(CO) did,t received any block', 'detailedDescription': "on arrival of the patients to the operative theatre and after placement of the standard monitoring general inhalational anesthesia was induced by face mask with sevoflurane (4-8%) in oxygen after IV cannula was secured patients received 1mic/kg fentanyl and intubation was facilitated by 0.5mg/kg atracurium. isoflurane 1-2% with oxygen was used for maintenance of anesthesia. after stabilization of the patient's hemodynamics and before skin incision erector spinae block or caudal block was performed with the patient in lateral position. after the block patients were flipped back to their normal supine position, surgery took place 10 min after injection of local anesthetic. after termination of surgery reversal of the atracurium was done by giving neostigmine in a dose of 0.04mg/kg and atropine 0.02mg/kg and awake extubation was done"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pediatric patients aged 2-6 years scheduled for lower abdominal surgery under general anesthesia\n\nExclusion Criteria:\n\n* parent refusal\n* spinal and meningeal anomalies\n* mental retardation\n* blood disease\n* infection at site of injection\n* drug allergy'}, 'identificationModule': {'nctId': 'NCT04690894', 'briefTitle': 'Erector Spinae Muscle Block Versus Caudal Block by Sonar in Pediatrics Undergoing Lower Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Ultrasound-guided Erector Spinae Muscle Block Versus Ultrasound-guided Caudal Block in Pediatric Patient Undergoing Lower Abdominal Surgery', 'orgStudyIdInfo': {'id': '266:7/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae group', 'description': 'the child received ultrasound-guided erector spinae muscle block in a dose of 0.4mg/kg of 0.25%bupivacaine between the 10th transverse process and erector spinae muscle', 'interventionNames': ['Procedure: erector spinae block - caudal block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'caudal group', 'description': 'child received ultrasound-guided caudal block in a dose of 2.5mg/kg of bupivacaine 0.25%', 'interventionNames': ['Procedure: erector spinae block - caudal block']}, {'type': 'NO_INTERVENTION', 'label': 'control', 'description': "child didn't received any regional block"}], 'interventions': [{'name': 'erector spinae block - caudal block', 'type': 'PROCEDURE', 'description': 'the child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered', 'armGroupLabels': ['Erector spinae group', 'caudal group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Ibrahim Talaat, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Shadwa Rabea Mohamed', 'investigatorAffiliation': 'Minia University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-17', 'type': 'RELEASE'}, {'date': '2021-04-12', 'type': 'RESET'}, {'date': '2021-06-01', 'type': 'RELEASE'}, {'date': '2021-06-22', 'type': 'RESET'}, {'date': '2021-07-19', 'type': 'RELEASE'}, {'date': '2021-08-12', 'type': 'RESET'}, {'date': '2021-09-09', 'type': 'RELEASE'}, {'date': '2021-10-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shadwa Rabea Mohamed, lecturer, Minia University'}}}}