Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:58 AM
Study NCT ID:
NCT05353218
Status:
COMPLETED
Last Update Posted:
2023-04-28
First Post:
2022-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized, Prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-27', 'studyFirstSubmitDate': '2022-04-24', 'studyFirstSubmitQcDate': '2022-04-28', 'lastUpdatePostDateStruct': {'date': '2023-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patient needed supplemental local anesthetic', 'timeFrame': 'Intraoperative 2-3 hours', 'description': 'If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon.'}], 'secondaryOutcomes': [{'measure': 'Amount of supplemental local anesthetic', 'timeFrame': 'Intraoperative 2-3 hours', 'description': 'If patients complain about pain above visual analog scale 3, 4ml 1% lidocaine is injected by surgeon.'}, {'measure': "Duration of blocks' application", 'timeFrame': 'Up to 15 minutes', 'description': 'time from the insertion of probe to the removal of needle from skin'}, {'measure': 'Region where patient needs supplemental local anesthetic', 'timeFrame': 'Intraoperative 2-3 hours', 'description': 'Region where supplemental lidocaine is injected by surgeon'}, {'measure': 'Amount of remifentanil', 'timeFrame': 'Intraoperative 2-3 hours', 'description': 'Amount of remifentanil (0.02mcg/kg/min) infused during surgery for sedation.'}, {'measure': 'Pain assessment', 'timeFrame': 'Intraoperative 2-3 hours', 'description': 'Pain assessment will be assessed using visual analog scale (VAS 0 to 10; 0: no pain, 10: the worst pain imaginable )'}, {'measure': 'Complications', 'timeFrame': 'Up to 24 hours', 'description': "Hematoma, dysphagia, hoarseness, facial paralysis, Horner's syndrome, intravascular or intrathecal injection"}, {'measure': "Patient's satisfaction", 'timeFrame': 'Up to 24 hours', 'description': 'Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)'}, {'measure': "Surgeon's satisfaction", 'timeFrame': 'Up to 24 hours', 'description': 'Likert scale:1-5 (1: very dissatisfied, 5: very satisfied)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cervical plexus block', 'Endarterectomy, Carotid'], 'conditions': ['Anesthesia']}, 'referencesModule': {'references': [{'pmid': '41272478', 'type': 'DERIVED', 'citation': 'Turhan O, Sivrikoz N, Canbolat N, Demirel EE, Altun D, Sungur Z. Ultrasound-guided intermediate versus deep cervical plexus block for carotid endarterectomy: a randomized controlled study. BMC Anesthesiol. 2025 Nov 21;25(1):581. doi: 10.1186/s12871-025-03460-w.'}]}, 'descriptionModule': {'briefSummary': 'Cervical plexus blocks are regional methods used in carotid endarterectomy. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep. These three blocks can be used alone or combined. The aim of this study is to evaluate the effectiveness of ultrasound-guided intermediate and deed cervical plexus block in patients undergoing carotid endarterectomy.', 'detailedDescription': 'Carotid endarterectomy is a surgical method used to treat occlusive lesions of the carotid. Regional anesthesia is preferred because it allows for consciousness control and neurological examination during the operation. Cervical plexus blocks are regional methods used in carotid endarterectomy. It is a regional technique in which the cervical spinal nerves (C2-C3-C4) are blocked with a local anesthetic agent from different regions. Cervical plexus blocks consist of three blocks: superficial, intermediate and deep, depending on the depth at which the local anesthetic agent is infiltrated. According to the preference of the clinician for the purpose of anesthesia, these three blocks can be used separately or combined. It is mentioned that all three blocks provide sufficient anesthesia for carotid endarterectomy surgery to be performed.\n\nIn the study, investigators planned to evaluate the effectiveness of ultrasound-guided intermediate and deep cervical plexus blocks in patients undergoing carotid endarterectomy by comparing the number of patients who need additional local anesthetics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for carotid endarterectom y surgery.\n\nExclusion Criteria:\n\n* Local infection\n* Previous ipsilateral surgery\n* Radiotherapy\n* Conversion to general anesthesia\n* Known bleeding disorders\n* Known allergy of local anesthetic'}, 'identificationModule': {'nctId': 'NCT05353218', 'briefTitle': 'Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Efficacy of Ultrasound-Guided Intermediate Versus Deep Cervical Plexus Block for Carotid Endarterectomy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021/923'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group intermediate cervical plexus block (GI)', 'description': 'Patients anesthetized with intermediate cervical plexus block.', 'interventionNames': ['Procedure: Intermediate cervical plexus block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group deep cervical plexus block (GD)', 'description': 'Patients anesthetized with deep cervical plexus block.', 'interventionNames': ['Procedure: Deep cervical plexus block']}], 'interventions': [{'name': 'Intermediate cervical plexus block', 'type': 'PROCEDURE', 'description': 'Intermediate cervical plexus block will be applied in transverse plane using posterior approach at C4.', 'armGroupLabels': ['Group intermediate cervical plexus block (GI)']}, {'name': 'Deep cervical plexus block', 'type': 'PROCEDURE', 'description': 'Deep cervical plexus block will be appliedin transverse plane using anterior approach at C2-3-4.', 'armGroupLabels': ['Group deep cervical plexus block (GD)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Istanbul Faculty of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist', 'investigatorFullName': 'Ozlem Turhan', 'investigatorAffiliation': 'Istanbul University'}}}}