Ignite Creation Date:
2025-12-24 @ 4:31 PM
Ignite Modification Date:
2026-02-25 @ 6:52 PM
Study NCT ID:
NCT02880566
Status:
UNKNOWN
Last Update Posted:
2016-08-26
First Post:
2016-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-08-23', 'studyFirstSubmitDate': '2016-08-23', 'studyFirstSubmitQcDate': '2016-08-23', 'lastUpdatePostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hemodynamic stability', 'timeFrame': '5 minutes', 'description': 'Increased in mean arterial pressure or heart rate of more than 15 % within 5 minutes of head pinning'}], 'secondaryOutcomes': [{'measure': 'Cumulative intraoperative remifentanil consumption', 'timeFrame': '24 hours'}, {'measure': 'Cumulative postoperative morphine consumption', 'timeFrame': '48 hours'}, {'measure': 'Postoperative pain scores', 'timeFrame': '48 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Craniotomy']}, 'referencesModule': {'references': [{'pmid': '33060491', 'type': 'DERIVED', 'citation': 'Carella M, Tran G, Bonhomme VL, Franssen C. Influence of Levobupivacaine Regional Scalp Block on Hemodynamic Stability, Intra- and Postoperative Opioid Consumption in Supratentorial Craniotomies: A Randomized Controlled Trial. Anesth Analg. 2021 Feb 1;132(2):500-511. doi: 10.1213/ANE.0000000000005230.'}]}, 'descriptionModule': {'briefSummary': 'Prospective randomised double-blinded placebo-controlled trial on the efficacy of scalp blocks on hemodynamic stability and opioid consumption during and after craniotomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective craniotomy for supratentorial lesion\n\nExclusion Criteria:\n\n* Allergy to local anaesthetic\n* Psychiatric disease\n* Inability to consent\n* Uncontrolled intracranial hypertension'}, 'identificationModule': {'nctId': 'NCT02880566', 'briefTitle': 'Efficacy of Scalp Block on Hemodynamic Stability and Opioid Consumption During Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'orgStudyIdInfo': {'id': 'anesneuro2016001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Full scalp block performed with a total of 30 ml of levobupivacaine 0.33 %.', 'interventionNames': ['Procedure: Scalp block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Full scalp block performed with a total of 30 ml of normal saline.', 'interventionNames': ['Procedure: Scalp block']}], 'interventions': [{'name': 'Scalp block', 'type': 'PROCEDURE', 'description': 'Full scalp block', 'armGroupLabels': ['Control', 'Treatment']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor and Chair', 'investigatorFullName': 'Jean François Brichant', 'investigatorAffiliation': 'University of Liege'}}}}