Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT06561269
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-20
First Post:
2024-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Multifidus Plane Block Versus Caudal Block for Hypospadias
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007021', 'term': 'Hypospadias'}], 'ancestors': [{'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D010409', 'term': 'Penile Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-18', 'studyFirstSubmitDate': '2024-06-02', 'studyFirstSubmitQcDate': '2024-08-18', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'is to measure the first time to rescue analgesia postoperative (24 hours).', 'timeFrame': '24 hours postoperative', 'description': 'Measure the first time to rescue analgesia post operative'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': 'start to end of surgery', 'description': 'measuring HR changes'}, {'measure': 'Blood pressure', 'timeFrame': 'start to end of the surgery.', 'description': 'measuring BP changes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Hypospadias', 'caudal block'], 'conditions': ['Hypospadias', 'Caudal Block']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the safety and efficacy of ultrasound-guided sacral multifidus plane block and compare its analgesic effect to ultrasound-guided caudal block in pediatric patients undergoing hypospadias surgery under general anesthesia', 'detailedDescription': 'Peri-operative pain management in pediatric surgeries is considered a challenging issue for the anesthesiologists. The usage of regional anesthesia in association with general anesthesia (GA) is a simple intraoperative way that reduces (GA) requirements and side effects. Recently, paraspinal fascial plane block, the sacral multifidus plane block (MPB), was used successfully in infants. The study has been designed to determine the effect of MPB versus caudal epidural block to control peri-operative pain in hypospadias surgeries in children.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD'], 'maximumAge': '7 Years', 'minimumAge': '1 Year', 'genderBased': True, 'genderDescription': 'Children aged (1 -7) years old.All patients will be of ASA classification I, II physical status', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ⦁ Children aged (1 -7) years old.\n\n * All patients will be of ASA classification I, II physical status\n\nExclusion Criteria:\n\n* ⦁ Parents refusing to participate are excluded from the trial.\n\n * Children who had spinal anomalies, altered mental status.\n * A history of developmental delay.\n * Blood diseases: Coagulopathy or anaemia.\n * Infection at the site of injection.\n * Drug allergy.'}, 'identificationModule': {'nctId': 'NCT06561269', 'briefTitle': 'Multifidus Plane Block Versus Caudal Block for Hypospadias', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Ultrasound_guided Multifidus Plane Block Versus Ultrasound_guided Caudal Block for Pediatric Hypospadias Surgery: a Randomized Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'MD73/2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Multifidus plane block (MPB) group', 'description': 'Participants will be injected bupivacaine at the fascial plane between the multifidus muscle and the median sacral crests of S2 and S3', 'interventionNames': ['Procedure: Multifidus plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Caudal block (CB) group', 'description': 'Participants will be injected by bupivacaine, between the two sacral cornua', 'interventionNames': ['Procedure: caudal block']}], 'interventions': [{'name': 'Multifidus plane block', 'type': 'PROCEDURE', 'description': 'Using the "in-plane" technique,The fascial plane between the multifidus muscle and the median sacral crests of S2 and S3, will be injected by bupivacaine.', 'armGroupLabels': ['Multifidus plane block (MPB) group']}, {'name': 'caudal block', 'type': 'PROCEDURE', 'description': 'The ultrasound transducer will first be placed transversely at the midline to obtain the transverse view of sacral hiatus. At this level, the ultrasound transducer is rotated 90 degrees to obtain the longitudinal view of sacral hiatus. The block needle is inserted using the "in-plane" technique.', 'armGroupLabels': ['Caudal block (CB) group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'radwa tarek, master', 'role': 'CONTACT', 'email': 'radwatarek@med.asu.edu.eg', 'phone': '01093024325'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Radwa Tarek', 'investigatorAffiliation': 'Ain Shams University'}}}}