Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT04945694
Status:
UNKNOWN
Last Update Posted:
2021-06-30
First Post:
2021-06-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015742', 'term': 'Propofol'}, {'id': 'D000077149', 'term': 'Sevoflurane'}, {'id': 'D001279', 'term': 'Atracurium'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D008738', 'term': 'Methyl Ethers'}, {'id': 'D004987', 'term': 'Ethers'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D044182', 'term': 'Benzylisoquinolines'}, {'id': 'D007546', 'term': 'Isoquinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-08', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-06-22', 'studyFirstSubmitDate': '2021-06-13', 'studyFirstSubmitQcDate': '2021-06-22', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative pain assessment', 'timeFrame': 'Postoperative day 1', 'description': 'Postoperative pain will be assessed using the modified objective pain score (OPDS) in children.'}, {'measure': 'Total dose of fentanyl requirements', 'timeFrame': 'intraoperative and 24 hrs postoperatively', 'description': 'Total dose of fentanyl requirements'}], 'secondaryOutcomes': [{'measure': 'Serum cortisol levels', 'timeFrame': 'Basal and one-hour postoperatively'}, {'measure': 'Heart rate [HR]', 'timeFrame': 'before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum'}, {'measure': 'Invasive mean arterial blood pressure [MAP]', 'timeFrame': 'before induction of anesthesia (basal value), after induction of anesthesia, after skin incision, after sternotomy, 15 min after CPB and after the closure of sternum'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pediatric Patients', 'Congenital Heart Surgery']}, 'descriptionModule': {'briefSummary': 'Cardiac surgical patients often experience significant postoperative pain at the median sternotomy site.\n\nIn pediatric cardiac surgery, the recommended pre bypass dose of fentanyl to blunt the hemodynamic and metabolic stress response is 25-50 µg/kg Today lower doses are often used in order to achieve early extubation at such doses there is no guarantee that the stress response is completely abolished one way to overcome this problem is the use of the local anesthetic technique Regional anesthetic techniques reduce pain for up to 24 hours after cardiac surgery in children.\n\nPectointercostal fascial block was first described by de la Torre in patients undergoing breast surgery. This novel technique blocks the anterior cutaneous nerve which is a branch of the intercostal nerve that gives sensory supply to the skin.', 'detailedDescription': 'The aim of the current study is to detect the effectiveness of pecto-intercostal fascial block in relieving postoperative pain in noncyanotic pediatric patients undergoing elective cardiac surgery the primary goal of this randomized study is to compare the postoperative pain score in the first postoperative 24 hours and to detect total dose of fentanyl requirements. The secondary goals are intraoperative hemodynamic stress response to surgical stimuli, analgesic consumption in the studied groups, cross-clamping and bypass time, time to extubation, intensive care length of stay, and postoperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On pump\n* Elective repair of congenital simple left to right intracardiac shunt\n* Median sternotomy\n\nExclusion Criteria:\n\n* Refusal of their guardians\n* Redo cardiac surgery\n* Previous back injury\n* Previous back surgery\n* Kyphoscoliosis\n* Local infection of the skin and subcutaneous tissue at the site of needle puncture\n* Hypersensitivity to local anesthetics\n* Coagulation disorders\n* Renal disease\n* Hepatic disease\n* Pulmonary disease\n* Heart failure\n* Moderate to severe pulmonary hypertension.'}, 'identificationModule': {'nctId': 'NCT04945694', 'briefTitle': 'Pain Management of Pecto-intercostal Fascial Block Versus Intravenous Fentanyl After Pediatric Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Ultrasound-Guided Bilateral Pecto-intercostal Fascial Block Versus Intravenous Fentanyl for Postoperative Pain Management After Pediatric Cardiac Surgery A Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'MD/ 21.04.462'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ultrasound-guided bilateral pecto-intercostal fascial block', 'description': 'Patients will receive bilateral ultrasound-guided pecto-intercostal fascial block', 'interventionNames': ['Other: Ultrasound-guided bilateral pecto-intercostal fascial block', 'Drug: Propofol', 'Drug: Sevoflurane', 'Drug: Atracurium', 'Device: ultrasound']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intravenous fentanyl', 'description': 'Patients will receive only incremental doses of intravenous fentanyl', 'interventionNames': ['Drug: Intravenous fentanyl', 'Drug: Propofol', 'Drug: Sevoflurane', 'Drug: Atracurium']}], 'interventions': [{'name': 'Ultrasound-guided bilateral pecto-intercostal fascial block', 'type': 'OTHER', 'description': '\\- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED', 'armGroupLabels': ['Ultrasound-guided bilateral pecto-intercostal fascial block']}, {'name': 'Intravenous fentanyl', 'type': 'DRUG', 'description': 'In this group, patients will receive only incremental doses of intravenous fentanyl', 'armGroupLabels': ['Intravenous fentanyl']}, {'name': 'Propofol', 'type': 'DRUG', 'description': 'Propofol anesthesia', 'armGroupLabels': ['Intravenous fentanyl', 'Ultrasound-guided bilateral pecto-intercostal fascial block']}, {'name': 'Sevoflurane', 'type': 'DRUG', 'description': 'Sevoflurane anesthesia', 'armGroupLabels': ['Intravenous fentanyl', 'Ultrasound-guided bilateral pecto-intercostal fascial block']}, {'name': 'Atracurium', 'type': 'DRUG', 'description': 'Intravenous atracurium', 'armGroupLabels': ['Intravenous fentanyl', 'Ultrasound-guided bilateral pecto-intercostal fascial block']}, {'name': 'ultrasound', 'type': 'DEVICE', 'description': 'ultrasound-guided block', 'armGroupLabels': ['Ultrasound-guided bilateral pecto-intercostal fascial block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '050', 'city': 'Al Mansurah', 'state': 'DK', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed A Ghanem, MD', 'role': 'CONTACT', 'email': 'mohamed.abdel_latif@yahoo.com', 'phone': '00201067883998'}, {'name': 'Enas Abd Elmotlb, MD', 'role': 'CONTACT', 'email': 'sevo2006@gmail.com', 'phone': '00201005401236'}, {'name': 'Sameh Ghareeb, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mohamed A Salama, M.Sec', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Mansoura University', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'centralContacts': [{'name': "Mohamed A Ghanem, MD'", 'role': 'CONTACT', 'email': 'mohamed.abdel_latif@yahoo.com', 'phone': '00201067883998'}, {'name': 'Enas Abd Elmotlb, MD', 'role': 'CONTACT', 'email': 'sevo2006@gmail.com', 'phone': '00201005401236'}], 'overallOfficials': [{'name': 'Mohamed A Ghanem, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Assistant professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt'}, {'name': 'Enas Abd Elmotlb, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'will be available within 6 months of study completion', 'ipdSharing': 'YES', 'description': 'De -identified individual participant data for all primary and secondary outcome measures will be made available', 'accessCriteria': 'data access requests will be reviewed by an external independent review panel .requestors will be required to sign a data access agreement'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}