Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT04931693
Status:
COMPLETED
Last Update Posted:
2022-10-20
First Post:
2021-06-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PECs Block for Pacemaker Insertion in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER'], 'maskingDescription': 'An online randomization program (http://www.randomizer.org) will be used to generate random list and to allocate patients into two study groups: Random allocation numbers will be concealed in opaque closed envelops. The patient and investigator performing the block and assessing study outcomes will all be blinded to the study group allocation.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patient will be randomly assigned to two equal groups. conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg . and Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block .'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-19', 'studyFirstSubmitDate': '2021-06-05', 'studyFirstSubmitQcDate': '2021-06-17', 'lastUpdatePostDateStruct': {'date': '2022-10-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Post-operative pain score by The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale.', 'timeFrame': 'immediate, 6,12 ,18 and 24 hours after intervention', 'description': 'pain score'}], 'secondaryOutcomes': [{'measure': 'Total consumption of opioids.', 'timeFrame': 'immediate, 6,12 ,18 and 24 hours after intervention', 'description': 'morphine dose'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Complete Heart Block']}, 'referencesModule': {'references': [{'pmid': '23711654', 'type': 'RESULT', 'citation': 'Anderson R, Harukuni I, Sera V. Anesthetic considerations for electrophysiologic procedures. Anesthesiol Clin. 2013 Jun;31(2):479-89. doi: 10.1016/j.anclin.2013.01.005. Epub 2013 Feb 23.'}, {'pmid': '32201270', 'type': 'RESULT', 'citation': 'Yang JK, Char DS, Motonaga KS, Navaratnam M, Dubin AM, Trela A, Hanisch DG, McFadyen G, Chubb H, Goodyer WR, Ceresnak SR. Pectoral nerve blocks decrease postoperative pain and opioid use after pacemaker or implantable cardioverter-defibrillator placement in children. Heart Rhythm. 2020 Aug;17(8):1346-1353. doi: 10.1016/j.hrthm.2020.03.009. Epub 2020 Mar 20.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral pacemaker insertion in Children: Randomized Controlled Trial', 'detailedDescription': 'BACKGROUND Pectoral nerve blocks (PECs) can reduce intraprocedural anesthetic requirements and postoperative pain. Little is known about the utility of PECs in reducing pain and narcotic use after pacemaker (PM)placement in children. OBJECTIVE The purpose of this study was to determine whether PECs can decrease postoperative pain and opioid use after PM placement in children.\n\nMETHODS A single-center controlled trial of pediatric patients undergoing transvenous PM placement between 2020 and 2021 will be performed. Demographics, procedural variables, postoperative pain, and postoperative opioid usage will be compared between patients who undergone PECs and those who undergone conventional anesthetic (Control).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* congenital or post-operative heart block.\n\nExclusion Criteria:\n\n* ⦁ Redo patient\n\n * History of allergic reactions to local anesthetics.\n * Bleeding disorders with International Normalization Ratio( INR) \\> 1.5 and/or platelets \\< 50 000.\n * Rash or signs of infection at the injection site.\n * Emergency procedure'}, 'identificationModule': {'nctId': 'NCT04931693', 'briefTitle': 'PECs Block for Pacemaker Insertion in Children', 'organization': {'class': 'OTHER', 'fullName': 'Kasr El Aini Hospital'}, 'officialTitle': 'Evaluation of Ultrasound Guided Modified Pectoral Nerves Blocks in Transvenous Subpectoral Pacemaker Insertion in Children: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MS-316-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'control', 'description': 'conventional control group(C) (n=20) where20 children will receive IV paracetamol 20 mg / kg and atracurium top ups at a dose of 0.1mg/kg. every 30 minutes.', 'interventionNames': ['Drug: paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PECs', 'description': 'Pectoral nerves blocks group (P) (n=20) where 20 children will have PECs Block and atracurium top ups upon request.', 'interventionNames': ['Procedure: modifiedPECs block']}], 'interventions': [{'name': 'paracetamol', 'type': 'DRUG', 'otherNames': ['perfalgan'], 'description': 'iv post operative analgesia', 'armGroupLabels': ['control']}, {'name': 'modifiedPECs block', 'type': 'PROCEDURE', 'otherNames': ['PECs 2 block'], 'description': 'sonar guided pectoral nerve block', 'armGroupLabels': ['PECs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr Al Ainy Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kasr El Aini Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Ahmed Mohamed Mohamed Elhaddad', 'investigatorAffiliation': 'Kasr El Aini Hospital'}}}}