Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2026-03-05 @ 5:46 AM
Study NCT ID:
NCT02450734
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2015-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016893', 'term': 'Carotid Stenosis'}], 'ancestors': [{'id': 'D002340', 'term': 'Carotid Artery Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-20', 'studyFirstSubmitDate': '2015-05-19', 'studyFirstSubmitQcDate': '2015-05-20', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of anesthesia', 'timeFrame': 'immediate', 'description': 'assessed by the patient (quality scale) and absence of the need to general anesthesia'}], 'secondaryOutcomes': [{'measure': 'Hemodynamic stability', 'timeFrame': 'immediate during surgery', 'description': 'measurements of non invasive arterial pressure and heart rate'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ultrasound-guided intermediate cervical plexus block'], 'conditions': ['Carotid Artery Stenosis']}, 'referencesModule': {'references': [{'pmid': '22749369', 'type': 'RESULT', 'citation': 'Schechter MA, Shortell CK, Scarborough JE. Regional versus general anesthesia for carotid endarterectomy: the American College of Surgeons National Surgical Quality Improvement Program perspective. Surgery. 2012 Sep;152(3):309-14. doi: 10.1016/j.surg.2012.05.008. Epub 2012 Jun 27.'}, {'pmid': '20008914', 'type': 'RESULT', 'citation': 'Usui Y, Kobayashi T, Kakinuma H, Watanabe K, Kitajima T, Matsuno K. An anatomical basis for blocking of the deep cervical plexus and cervical sympathetic tract using an ultrasound-guided technique. Anesth Analg. 2010 Mar 1;110(3):964-8. doi: 10.1213/ANE.0b013e3181c91ea0. Epub 2009 Dec 15.'}, {'pmid': '21106978', 'type': 'RESULT', 'citation': 'Choquet O, Dadure C, Capdevila X. Ultrasound-guided deep or intermediate cervical plexus block: the target should be the posterior cervical space. Anesth Analg. 2010 Dec;111(6):1563-4; author reply 1564-5. doi: 10.1213/ANE.0b013e3181f1d48f. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Since stroke and myocardial ischemia are major causes of perioperative morbidity and mortality associated with carotid endarterectomy, monitoring the brain and ensuring the best hemodynamic stability are important goals of perioperative management.\n\nThe investigators conducted a prospective observational study about efficacy and safety of the ultrasound-guided intermediate cervical plexus block (CPB), with early (immediate postoperative) and mid-term (day 30) outcomes in awake patients undergoing carotid endarterectomy.', 'detailedDescription': 'From April 2011 to May 2013, all patients undergoing a carotid endarterectomy were informed of the study and prospectively included. The study was approved by our institutional ethical Review Board (CEPAR, Institut Mutualiste Montsouris Paris France). Oral consent was obtained from patients. Written informed consent of the patients to participate was not necessary according to the French law regarding observational study.\n\nThe anesthesiologist in charge of the patient recorded all the parameters of the ultrasound-guided intermediate cervical plexus block: facility and duration of block performance, local anesthetic volume, quality of anesthesia and surgical dissection, and adverse effects of the intermediate CPB. . Neurological status was assessed intraoperatively, in the postoperative setting and at one month after the procedure. Perioperative hemodynamic stability (intraoperative non invasive blood pressure variations) and pulse oxymetry were recorded. As well as ECG and cardiac Troponin I (cTnI) measurments performed the day before surgery and each morning during the 3 first postoperative days. Any clinical coronary or neurological event was recorded at one month.\n\nStatistical analysis was performed on Prism 6 for Mac OS X (Version 6.0c, www.graphpad.com). Data are presented as mean ± standard deviation (SD) for continuous data and number (percentage) for categorical data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing carotid endarterectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing carotid endarterectomy\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT02450734', 'briefTitle': 'Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Institut Mutualiste Montsouris'}, 'officialTitle': 'Safety and Efficiency of Ultrasound-guided Intermediate Cervical Plexus Block for Carotid Surgery', 'orgStudyIdInfo': {'id': 'IMM CEPAR : 2012-014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Carotid endarterectomy', 'description': 'Realisation of an ultrasound-guided intermediate cervical plexus block for anesthesia of carotid endarterectomy', 'interventionNames': ['Procedure: Ultrasound-guided intermediate cervical plexus block']}], 'interventions': [{'name': 'Ultrasound-guided intermediate cervical plexus block', 'type': 'PROCEDURE', 'armGroupLabels': ['Carotid endarterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'country': 'France', 'facility': 'Department of Anesthesia Institut Mutualiste Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Isabelle LEBLANC, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut Mutualiste Montsouris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut Mutualiste Montsouris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}