Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2026-01-05 @ 9:39 AM
Study NCT ID:
NCT03409068
Status:
COMPLETED
Last Update Posted:
2019-04-23
First Post:
2018-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
C2-C4 Compartment Block Versus Block of Costagliola, in TEAC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059226', 'term': 'Nociceptive Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-21', 'studyFirstSubmitDate': '2018-01-17', 'studyFirstSubmitQcDate': '2018-01-23', 'lastUpdatePostDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'somatic pain', 'timeFrame': '3 mounths after surgery', 'description': 'Somatic pain assessed by Numeric Pain Rating Scale for pain (the 11-point numeric scale ranges from \'0\' representing "no pain" to \'10\' representing the "worst pain imaginable"'}], 'secondaryOutcomes': [{'measure': 'Opiates request', 'timeFrame': '3 mounths after surgery', 'description': 'Request of opiates, assessed in mg of equianalgesic dose of morphine after 3 mouths from surgery'}, {'measure': 'Pregabalin request', 'timeFrame': '3 months', 'description': 'Pregabalin request in mg, 3 months after surgery'}, {'measure': 'Neuropathic pain', 'timeFrame': '3 months', 'description': 'Presence of neuropathic disturbances, assessed with von Frey hair test and Lindblom test'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Carotid thromboendarterectomy', 'Carotidodynia'], 'conditions': ['Somatic Pain', 'Neuropathic Pain']}, 'descriptionModule': {'briefSummary': 'C2-C4 compartment block compared to the Costaiola block, in the control of persistent postoperative pain (somatic and neuropathic) in patients undergoing carotid thromboendarterectomy', 'detailedDescription': 'A comparative analysis will assess the somatic pain (scores ≥4 on the NRS scale) and neurapathic pain (by the Lindblom roller and Von Frei hair tests) between group A (block group of the C2-C4 compartment ) and the control group B (block group according to Costagliola), during the 3 months after surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing to carotid thromboendarterectomy\n\nExclusion Criteria:\n\n* ASA status: 4\n* pregnancy\n* BMI \\> 39,99\n* neurological impairment\n* neck anatomical abnormalities\n* status of sepsis\n* coagulopathy\n* neck cancer\n* neck infections'}, 'identificationModule': {'nctId': 'NCT03409068', 'acronym': 'TEAC', 'briefTitle': 'C2-C4 Compartment Block Versus Block of Costagliola, in TEAC', 'organization': {'class': 'OTHER', 'fullName': "San Salvatore Hospital of L'Aquila"}, 'officialTitle': 'The Effectiveness of C2-C4 Compartment Block Versus Block of Costagliola, in the Control of Persistent Postoperative Pain in Patients Undergoing Carotid Thromboendarterectomy', 'orgStudyIdInfo': {'id': '0174363/2017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'C2-C4 compartment block', 'description': 'Experimental: the C2-C4 compartment anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenous muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.', 'interventionNames': ['Procedure: C2-C4 compartment anesthetic block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Costagliola block', 'description': 'Active Comparator: the Costagliola anesthetic block is performed by injecting Levobupivacaine 0.375% 20 mL injected in the posterior margin of the sternocleidomastoid muscle and along the anterior border of the same muscle.', 'interventionNames': ['Procedure: Costagliola block']}], 'interventions': [{'name': 'C2-C4 compartment anesthetic block', 'type': 'PROCEDURE', 'otherNames': ['Intermediate cervical plexus block'], 'description': 'C2-C4 compartment anesthetic block is performed by injecting levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenus muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.', 'armGroupLabels': ['C2-C4 compartment block']}, {'name': 'Costagliola block', 'type': 'PROCEDURE', 'otherNames': ['Superficial cervical plexus block'], 'description': 'Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle', 'armGroupLabels': ['Costagliola block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '67051', 'city': 'Avezzano', 'state': "L'Aquila", 'country': 'Italy', 'facility': 'SS Filippo and Nicola Academic Hospital of Avezzano', 'geoPoint': {'lat': 42.02896, 'lon': 13.42641}}], 'overallOfficials': [{'name': 'Emiliano Petrucci, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'SS Filippo and Nicola Academic Hospital of Avezzano'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "San Salvatore Hospital of L'Aquila", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Emiliano Petrucci', 'investigatorAffiliation': "San Salvatore Hospital of L'Aquila"}}}}