Ignite Creation Date:
2025-12-25 @ 3:14 AM
Ignite Modification Date:
2026-02-03 @ 4:16 AM
Study NCT ID:
NCT05323305
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2022-03-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2022-03-21', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the analgesic effectiveness of the two blocks on midline sternotomy pain,', 'timeFrame': 'from end of surgery till discharge from ICU (96 hours)', 'description': 'Postoperative pain evaluation after extubation will be done using the Visual Analogue Scale (VAS). a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between 0 "no pain" and 10 "worst pain."'}], 'secondaryOutcomes': [{'measure': 'pulmonary complications', 'timeFrame': 'from end of surgery till discharge from ICU (96 hours)', 'description': 'atelectasis and pneumonia'}, {'measure': 'length of stay in ICU', 'timeFrame': 'average 4 days', 'description': 'days from admission till discharge from ICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ultrasound, pectointercostal, Cardiac surgery'], 'conditions': ['Pain, Post Operative']}, 'descriptionModule': {'briefSummary': 'The study will be designed to compare the analgesic effect of ultrasound-guided pectointercostal fascial plane block versus tansversus thoracic plane block in adult cardiac surgery.', 'detailedDescription': 'A prospective study will be carried out in Alexandria Main University Hospitals on 60 adult patients planned for elective cardiac surgery, after approval of the Ethical Committee of Faculty of Medicine, Alexandria, and having an informed written consent taken from patients included in the study. Patients will be categorized into two equal groups; group P (n=30)) will receive ultrasound-guided pectointercostal fascial plane block and group T (n=30) will receive ultrasound-guided transversus thoracic plane block.\n\nAll patients will receive the ultrasound-guided block after induction of anesthesia and an equal booster dose of the same block before extubation in the ICU. Patients in both groups will also receive an ultrasound-guided bilateral serratus anterior plane block before extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult patient.\n2. Elective cardiac surgery.\n\nExclusion Criteria:\n\n1. Refusal to participate.\n2. Redo or urgent cardiac surgery.\n3. Local infection of the skin at the site of needle puncture.\n4. Allergy to bupivacaine.\n5. Coagulation disorders.\n6. Clinically significant liver or kidney disease, heart failure, moderate to severe pulmonary hypertension.\n7. when extubation is intentionally planned to be delayed'}, 'identificationModule': {'nctId': 'NCT05323305', 'briefTitle': 'Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Ultrasound Guided Pectointercostal Fascial Plane Block Versus Transversus Thoracic Plane Block In Adult Cardiac Surgery Patients: A Comparative Study', 'orgStudyIdInfo': {'id': '0305468'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pectointercostal Group (n=30)', 'description': 'They will receive ultrasound-guided pectointercostal fascial block after induction of anesthesia with equal dose before extubation in the intensive care.', 'interventionNames': ['Procedure: ultrasound guided regional block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transversus thoracic Group (n=30)', 'description': 'They will receive ultrasound-guided ultrasound-guided transversus thoracic plane block after induction of anesthesia with equal dose before extubation in the intensive care.', 'interventionNames': ['Procedure: ultrasound guided regional block']}], 'interventions': [{'name': 'ultrasound guided regional block', 'type': 'PROCEDURE', 'otherNames': ['ultrasound guided nerve block'], 'description': 'Bupivacaine injection by the use of ultrasound in the pectointercostal fascial plane in one group and in the trasversus thoracic plane in the other group.', 'armGroupLabels': ['Pectointercostal Group (n=30)', 'Transversus thoracic Group (n=30)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'facility': 'Alexandria University Hospitals', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'Islam Omar, MD', 'role': 'CONTACT', 'email': 'i_omar12@alexmed.edu.eg', 'phone': '+201227851759'}, {'name': 'Ibrahim Ibrahim, MD', 'role': 'CONTACT', 'phone': '01224336786'}], 'overallOfficials': [{'name': 'islam Omar, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university'}, {'name': 'Ibrahim Ibrahim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university'}, {'name': 'Moustafa Halwag, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of Anaesthesia and surgical intensive care, Faculty of medicine, Alexandria university'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Immediately after publication No end date', 'ipdSharing': 'YES', 'description': 'All of the individual participant data collected during the trial, after deidentification', 'accessCriteria': 'Any one who wishes to access the data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}