Ignite Creation Date:
2025-12-24 @ 2:51 PM
Ignite Modification Date:
2025-12-28 @ 1:14 AM
Study NCT ID:
NCT03734159
Status:
COMPLETED
Last Update Posted:
2020-07-07
First Post:
2018-11-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-03', 'studyFirstSubmitDate': '2018-11-05', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2020-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-06-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Show that the preoperative realization of a parasternal block limites the posology of remifentanil administered during sternotomies to maintain blood pressure and heart rate within recommended ranges', 'timeFrame': 'Intraoperative period : from intubation to sternal retractor setup', 'description': 'Maximal dose of remifentanil (morphine peak) required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during intubation, skin incision, sternotomy and sternal retractor setup'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic response : heart rate', 'timeFrame': 'Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup', 'description': 'Measure of heart rate in bpm'}, {'measure': 'Hemodynamic response : arterial blood pressure', 'timeFrame': 'Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup', 'description': 'Measure of diastolic and systolic arterial blood pressure in mmHg'}, {'measure': 'Hemodynamic response : patient state index', 'timeFrame': 'Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup', 'description': 'Measure of patient state index ranging from 0 to 100 (0=very deep anesthesia, 100=no hypnotic state)'}, {'measure': 'Dose of hypnotic drug', 'timeFrame': 'Intraoperative period : from induction of anesthesia to skin closure', 'description': 'Total amount of propofol administered during surgery'}, {'measure': 'Dose of analgesic drug', 'timeFrame': 'Intraoperative period : from induction of anesthesia to skin closure', 'description': 'Total amount of remifentanil administered during surgery'}, {'measure': 'Inflammatory response', 'timeFrame': '7 days', 'description': 'Serum concentrations of cytokines in pg/ml (composite : pro- (IL-6, IL-8, IL-1β, TNF-α, IFN-γ) and anti-inflammatory (IL-10) cytokines)'}, {'measure': 'Pain level during extubation: Numeric scale', 'timeFrame': '8 hours', 'description': 'Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)'}, {'measure': 'Complications', 'timeFrame': '7 days', 'description': 'Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia', 'Sternotomy'], 'conditions': ['Coronary Bypass Graft Stenosis']}, 'referencesModule': {'references': [{'pmid': '33990437', 'type': 'DERIVED', 'citation': 'Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.'}]}, 'descriptionModule': {'briefSummary': 'Patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. Episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia.\n\nDuring cardiac surgery by sternotomy, some maneuvers, e.g. intubation, skin incision, sternotomy and cannulation, may be associated with tachycardia and/or increases in blood pressure despite an adequate level of anesthesia. Usually these episodes are controlled by the administration of a high-dose of anesthetic agents.\n\nThe parasternal block, by bolus or continuous infusion through a single catheter, showed its effectiveness on postoperative pain after sternotomy. It allows a blocking of anterior branches of intercostal nerves at the lateral edge of the sternum; branches in charge of innervation of the sternum and the overlying skin surface.\n\nThe preoperative parasternal block, once general anesthesia performed, could provide an effective level of locoregional anesthesia of the chest wall, thus limiting the occurrence of episodes of tachycardia and / or hypertension without having to resort to massive doses of anesthetic agents during sternotomy in patients undergoing coronary bypass surgery.', 'detailedDescription': 'This randomized double blinded placebo-controlled clinical trial will include patients undergoing coronary artery bypass grafting.\n\nLocoregional anesthesia of the chest wall will be performed under ultrasound, once general anesthesia performed. A total volume of 60 ml of sodium chloride 0.9% (placebo group) or ropivacaine 0.25% (experimental group) divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) will be injected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing coronary artery bypass graft requiring sternotomy other than re-interventions and combined surgeries\n* Consent for participation\n* Affiliation to the french social security system\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Patients under protection of the adults (guardianship, curator or safeguard of justice)\n* Communication difficulties or neuropsychiatric disorder\n* Neuropathic disease\n* Constitutional coagulation disorders\n* Kidney insufficiency\n* Sensitivity to nonsteroidal anti-inflammatory drugs\n* Hypersensitivity to local anaesthetics\n* Chronic use of opioid analgesics\n* Corticosteroid treatment or immunosuppressive therapy\n* Autoimmune disease\n* Chronic pain syndrome or fibromyalgia\n* Emergency cardiac surgery\n* Hypovolemia'}, 'identificationModule': {'nctId': 'NCT03734159', 'acronym': 'PARA', 'briefTitle': 'The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery', 'organization': {'class': 'OTHER', 'fullName': 'CMC Ambroise Paré'}, 'officialTitle': 'Interest of Parasternal Block to Limit the Doses of Anesthetics Necessary for the Maintenance of Arterial Blood Pressure and Heart Rate in the Recommended Values During Sternotomy in Patients Undergoing Coronary Artery Bypass Graft', 'orgStudyIdInfo': {'id': '2018/07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'parasternal block', 'description': 'preoperative parasternal block by ropivacaine injection', 'interventionNames': ['Drug: Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'physiological serum', 'description': 'sodium chloride injection', 'interventionNames': ['Drug: sodium chloride 0.9%']}], 'interventions': [{'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Injection of 60 ml of ropivacaine 0.25% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)', 'armGroupLabels': ['parasternal block']}, {'name': 'sodium chloride 0.9%', 'type': 'DRUG', 'description': 'Injection of 60 ml of sodium chloride 0.9% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)', 'armGroupLabels': ['physiological serum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'state': 'Île-de-France Region', 'country': 'France', 'facility': 'CMC Ambroise Paré', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}], 'overallOfficials': [{'name': 'Sébastien Bloc, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMC Ambroise Paré'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CMC Ambroise Paré', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}