Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
Study NCT ID:
NCT05627869
Status:
UNKNOWN
Last Update Posted:
2023-07-11
First Post:
2022-11-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-08', 'studyFirstSubmitDate': '2022-11-01', 'studyFirstSubmitQcDate': '2022-11-23', 'lastUpdatePostDateStruct': {'date': '2023-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome will be total morphine consumption', 'timeFrame': '24 hours', 'description': 'Total morphine consumption within 24 hours according Visual Analogue Score (VAS) for sternal pain both during rest and with cough (ranging from 0 indicating no pain to 10 indicating extreme pain). A score ≤ 3 was considered acceptable for pain relief. Supplementary rescue analgesia was administered in the form of morphine IV 0.05 mg/kg (at VAS ≥ 4).'}], 'secondaryOutcomes': [{'measure': 'The secondary outcomes will be the first analgesic request time', 'timeFrame': '24 hours', 'description': 'Is the time to ask for the first postoperative analgesia (morphine), and will be calculated from extubation to patient reporting Visual Analogue Score (VAS) ≥ 4.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TTPB', 'PIFB'], 'conditions': ['Pain', 'Postoperative']}, 'referencesModule': {'references': [{'pmid': '38341525', 'type': 'DERIVED', 'citation': 'Mansour MA, Mahmoud HE, Fakhry DM, Kassim DY. Comparison of the effects of transversus thoracic muscle plane block and pecto-intercostal fascial block on postoperative opioid consumption in patients undergoing open cardiac surgery: a prospective randomized study. BMC Anesthesiol. 2024 Feb 10;24(1):63. doi: 10.1186/s12871-024-02432-w.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to compare the effects of TTPB vs PIFB on postoperative opioid consumption in patients undergoing open cardiac surgery.', 'detailedDescription': 'Cardiac surgery performed through median sternotomy is associated with significant postoperative pain.Poststernotomy pain leads to decreased patient satisfaction, delirium, cardiovascular complications (hypertension, tachycardia, arrhythmias), hyperglycemia and respiratory complications (bronchial secretion stasis, atelectasis and pneumonia).High-dose opioids can provide good postoperative analgesia for patients undergoing heart surgery. However, opioids have some side effects.The advent of ultrasound-guided regional anaesthesia led to the development of fascial plane chest wall block as transthoracic plane block and pectointercostal fascial block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age between 18 and 75 years.\n2. Patient scheduled to undergo elective on-pump cardiac surgery with sternotomy.\n3. American Society of Anesthesiologists classification of physical status \\< IV.\n\nExclusion Criteria:\n\n1. Emergency surgery.\n2. Off-pump surgery.\n3. Redo surgery.\n4. Ejection fraction less than 35%.\n5. Refusal of the patient.\n6. Known hypersensitivity to LA.\n7. Chronic opioid use or chronic pain patient.\n8. Psychiatric problems or communication difficulties.\n9. Liver insufficiency (defined as a serum bilirubin ≥ 34 μmol/l, albumin ≤ 35 g/dl, INR ≥ 1.7)\n10. Renal insufficiency (defined as a glomerular filtration rate \\< 44 ml/min).\n11. Obstructive sleep apnea syndrome.\n12. Coexisting hematologic disorders.\n13. Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT05627869', 'briefTitle': 'Effects of TTPB vs PIFB on Opioid Consumption in Patients After Cardiac Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Beni-Suef University'}, 'officialTitle': 'Comparison of Effects of Transversus Thoracic Muscle Plane Block vs Pecto-intercostal Fascial Block on Postoperative Opioid Consumption in Patients Undergoing Open Cardiac Surgery: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Mariana AbdElsayed'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transversus thoracic muscle plane block', 'description': 'TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.', 'interventionNames': ['Procedure: Transversus thoracic plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Pecto-intercostal fascial plane block', 'description': 'PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.', 'interventionNames': ['Procedure: Pecto intercostal fascial block']}], 'interventions': [{'name': 'Transversus thoracic plane block', 'type': 'PROCEDURE', 'otherNames': ['sunnypivacaine'], 'description': 'TTPB group will receive bilateral ultrasound-guided transversus thoracic muscle plane block using 20 ml of bupivacaine 0.25% for each side.', 'armGroupLabels': ['Transversus thoracic muscle plane block']}, {'name': 'Pecto intercostal fascial block', 'type': 'PROCEDURE', 'otherNames': ['sunnypivacaine'], 'description': 'PIFB group will receive bilateral ultrasound-guided Pecto-intercostal fascial plane block using 20 ml of bupivacaine 0.25% for each side.', 'armGroupLabels': ['Pecto-intercostal fascial plane block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Benisuef', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'مريانة عبد السيد سليمان, MD', 'role': 'CONTACT', 'email': 'mrmrsyk4@gmail.com', 'phone': '01222960009'}], 'facility': 'Benisuef University Hospital'}], 'centralContacts': [{'name': 'Mariana A Mansour, lecturer', 'role': 'CONTACT', 'email': 'mrmrsyk4@gmail.com', 'phone': '01222960009'}], 'overallOfficials': [{'name': 'Mariana A Mansour, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Benisuef university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'TITLE'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beni-Suef University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of anaesthesia, surgical intensive care and pain managment', 'investigatorFullName': 'Mariana Soliman', 'investigatorAffiliation': 'Beni-Suef University'}}}}