Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-28 @ 4:29 AM
Study NCT ID:
NCT05518266
Status:
UNKNOWN
Last Update Posted:
2022-09-15
First Post:
2022-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonar Guided vs Surgeon Delivered Parasternal Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 88}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-12', 'studyFirstSubmitDate': '2022-08-24', 'studyFirstSubmitQcDate': '2022-08-24', 'lastUpdatePostDateStruct': {'date': '2022-09-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in postoperative pain score', 'timeFrame': '24 hours', 'description': 'Postoperative pain score will be measured after extubation at 0, 3, 6, 12, 16, 20, and 24 hours, using a visual analog scale (VAS). We are interested in the time at which postoperative pain is most severe.\n\nThe pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations, The pain VAS is a continuous scale comprised of a horizontal (HVAS) or vertical (VVAS) line, usually, 10centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme.\n\nA score of 0 is "no pain and a score of 10 is "worst imaginable pain"'}], 'secondaryOutcomes': [{'measure': 'Amount of rescue analgesia', 'timeFrame': '24 hours', 'description': 'Amount of rescue analgesia (total dose of fentanyl) during the first 24 hours after extubation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pectointercostal fascial plane block', 'parasternal block'], 'conditions': ['Parasternal Intercostal Nerve Block']}, 'referencesModule': {'references': [{'pmid': '31054241', 'type': 'RESULT', '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.'}, {'pmid': '25796483', 'type': 'RESULT', 'citation': 'Huang AP, Sakata RK. [Pain after sternotomy - review]. Rev Bras Anestesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjan.2014.09.003. Epub 2015 Mar 18. Portuguese.'}, {'pmid': '31281217', 'type': 'RESULT', 'citation': 'Vilite B, Strike E, Rutka K, Leibuss R. Pain management in intensive care unit patients after cardiac surgery with sternotomy approach. Acta Med Litu. 2019;26(1):51-63. doi: 10.6001/actamedica.v26i1.3956.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether the use of post-incisional surgeon-delivered parasternal block is at least non-inferior in relieving postoperative pain in adult patients scheduled for cardiac surgery involving sternotomy compared with ultrasound-guided post-incisional PIFB.', 'detailedDescription': 'Patients will be randomly allocated (using a sequence of computer-generated random numbers) into one of two groups (44 patients in each); group P (ultrasound guided parasternal; PIFP block) and group S (surgeon delivered parasternal block).\n\n1. group P (ultrasound guided parasternal; PIFP block): Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance\n2. Group S (surgeon delivered parasternal block). Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: from 18 to 75 years.\n* Rheumatic heart disease needing elective valve replacement (mitral, aortic, or double valve replacement) via median sternotomy and under CPB (cardiopulmonary bypass)\n* Hemodynamic stability (no evidence of heart failure, not on vasoactive drugs, and not on mechanical ventilation).\n\nExclusion Criteria:\n\n* • Previous, urgent, or emergent cardiac surgery.\n\n * Patients undergoing coronary artery bypass grafting (CABG)\n * local infection of the skin at the site of needle puncture,\n * Allergy to bupivacaine,\n * Coagulation disorders,\n * Clinically significant liver or kidney disease,\n * Heart failure or severe pulmonary hypertension.\n * severe renal, pulmonary, liver, or endocrine systemic disease,'}, 'identificationModule': {'nctId': 'NCT05518266', 'briefTitle': 'Sonar Guided vs Surgeon Delivered Parasternal Block', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Ultrasound-guided Versus Surgeon Delivered Post-incisional Parasternal Block in Adult Patients Undergoing Open Cardiac Surgery: Are They the Same?', 'orgStudyIdInfo': {'id': 'PIFPB Adults'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'US-guided post-incisional PIFB', 'description': 'Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of the sternum after skin closure under ultrasound guidance', 'interventionNames': ['Procedure: US-guided Parasternal block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Surgeon-delivered post-incisional parasternal block', 'description': 'Just before wiring the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.', 'interventionNames': ['Procedure: Surgeon-delivered parasternal block']}], 'interventions': [{'name': 'US-guided Parasternal block', 'type': 'PROCEDURE', 'otherNames': ['Pectointercostal fascial plane block'], 'description': 'Bupivacaine 0.25 % will be injected into the fascial plane between the pectoralis major muscle and external intercostal muscle or costal cartilages on each side of sternum after skin closure under ultrasound guidance', 'armGroupLabels': ['US-guided post-incisional PIFB']}, {'name': 'Surgeon-delivered parasternal block', 'type': 'PROCEDURE', 'description': 'Just before wiring of the sternum, the surgeon will inject bupivacaine 0.25 % in 4 mL aliquots into the anterior (2nd-6th) intercostal spaces on each side about 2 cm lateral to the sternal edge with a total volume of 40 mL under direct vision.', 'armGroupLabels': ['Surgeon-delivered post-incisional parasternal block']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohamed Ahmed Ali Ahmed', 'role': 'CONTACT', 'email': 'drmoali@yahoo.com', 'phone': '+201008707460'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Mohamed Ahmed Ali Ahmed', 'investigatorAffiliation': 'Assiut University'}}}}