Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT05691920
Status:
UNKNOWN
Last Update Posted:
2023-01-25
First Post:
2023-01-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Regional Blocks for CABG Artery Bypass Graft Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double blinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-21', 'studyFirstSubmitDate': '2023-01-11', 'studyFirstSubmitQcDate': '2023-01-11', 'lastUpdatePostDateStruct': {'date': '2023-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative fentanyl requirements for 24 hours', 'timeFrame': '24 hours postoperatively', 'description': 'Visual analogue score will be measured every 2 hours'}], 'secondaryOutcomes': [{'measure': 'Visual analogue score', 'timeFrame': '24 hours postoperatively', 'description': 'Visual analogue score will be measured every 2 hours'}, {'measure': 'Rescue analgesia', 'timeFrame': '24 hours postoperatively', 'description': '0.5 microgram/kg fentanyl will be given if visual analogue score more than 4'}, {'measure': 'Side effects', 'timeFrame': '24 hours postoperatively', 'description': 'Any side effect related to fentanyl or block technique will be detected and treated properly'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia After Coronary Artery Bypass Graft Surgery']}, 'referencesModule': {'references': [{'pmid': '31054241', 'type': 'BACKGROUND', 'citation': 'Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153.'}]}, 'descriptionModule': {'briefSummary': 'Pain control after CABG is an essential step to guard against postoperative complications such as lung atelectasis. This major step can be achieved by opioids or regional blocks.\n\nRegional blocks allow better pain control and avoid side effects of opioid based pain control', 'detailedDescription': 'Ultrasound guided External oblique intercostal plane block and pectointercostal plane block for perioperative analgesia in coronary artery bypass graft surgery: Prospective randomized controlled study\n\nIntroduction:\n\nPain control is a vital component to achieve enhanced recovery after cardiac surgery. Effective postoperative pain control will reduce the incidence of numerous postoperative complications, can facilitate early mobilization and may result in earlier recovery.\n\nPain control is historically achieved by the administration of opioids, which is associated with well-documented side effects, such as sedation, respiratory depression, pruritus, hallucinations and postoperative nausea and vomiting (PONV). Enhanced recovery following coronary artery bypass grafting (CABG) has gained attention even though there is limited evidence on the efficacy and effectiveness of existing analgesic techniques.\n\nThe external oblique intercostal plane and pectointercostal plane blocks are a new modality that will be used to improve pain-related outcomes after CABG surgery, and has not been extensively investigated. Therefore, we will test the hypothesis that external oblique intercostal plane and pectointercostal plane blocks can reduce cumulative opioid consumption for the patients undergoing CABG surgery when added to conventional multi-model intravenous analgesic technique.\n\nThe aim of this prospective comparative investigation is to assess the impact of external oblique intercostal plane and pectointercostal plane blocks in a multimodal perioperative analgesic regimen and any related side effects in patients undergoing CABG surgery.\n\nPatients and Methods:\n\nA prospective study will be carried out in Alexandria Main University Hospital on 120 American society of anaesthesiologists (ASA) II, III physical status aged 40-60 years scheduled for major upper abdominal surgery, after approval of the Medical Ethics Committee and an informed written consent. Patients will be categorized into two equal groups, group I (60) will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks and group II (60) will be subjected to fentanyl infusion at a rate of 1μg/kg/h. During the patient stay in the ICU, total analgesic requirements will be measured in both groups. Also, sedation level, duration of intubation and length of ICU stay will be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing CABG surgery\n\nExclusion Criteria:\n\n* BMI above 40\n* allergy for drugs used\n* complicated cases\n* patient refusal\n* chronic opioid use\n* cognitive dysfunction\n* chronic kidney disease'}, 'identificationModule': {'nctId': 'NCT05691920', 'briefTitle': 'Regional Blocks for CABG Artery Bypass Graft Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Ultrasound Guided External Oblique Intercostal Plane Block and Pectointercostal Plane Block for Perioperative Analgesia in Coronary Artery Bypass Graft Surgery: Prospective Randomized Controlled Study', 'orgStudyIdInfo': {'id': '0305397'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Block group', 'description': 'Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks', 'interventionNames': ['Procedure: Pectointercostal plane block and external oblique intercostal plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Opioid group', 'description': 'Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h', 'interventionNames': ['Procedure: Fentanyl infusion']}], 'interventions': [{'name': 'Pectointercostal plane block and external oblique intercostal plane block', 'type': 'PROCEDURE', 'description': 'Patients will be subjected to bilateral external oblique intercostal plane and pectointercostal plane blocks', 'armGroupLabels': ['Block group']}, {'name': 'Fentanyl infusion', 'type': 'PROCEDURE', 'description': 'Patients will be subjected to fentanyl infusion at a rate of 1μg/kg/h', 'armGroupLabels': ['Opioid group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Abdelmawla, MD', 'role': 'CONTACT', 'email': 'M_abdelmawla12@alexmed.edu.eg', 'phone': '+201114748411'}, {'name': 'Maha Ghanem, MD', 'role': 'CONTACT', 'email': 'Ghanemmaha@yahoo.com', 'phone': '+20127498435'}]}, 'ipdSharingStatementModule': {'url': 'http://www.alexu.edu.eg', 'infoTypes': ['STUDY_PROTOCOL', 'CSR'], 'timeFrame': 'One year', 'ipdSharing': 'YES', 'description': 'Data will be shared on request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}