Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-03-03 @ 12:44 AM
Study NCT ID:
NCT02057367
Status:
COMPLETED
Last Update Posted:
2016-07-27
First Post:
2013-09-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scalp Nerve Block and Opioid Consumption in Brain Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'C066096', 'term': 'PAVE protocol 2'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-25', 'studyFirstSubmitDate': '2013-09-26', 'studyFirstSubmitQcDate': '2014-02-06', 'lastUpdatePostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'extubation', 'timeFrame': 'end of surgery, before transferring to the intensive care unit', 'description': 'The rate of immediate extubation before transferring to the intensive care unit (ICU) compared between patients who received 0.5% plain Marcaine and 0.9% normal saline solution.'}], 'primaryOutcomes': [{'measure': 'Intraoperative opioid consumption', 'timeFrame': 'During the supratentorial craniotomy surgery', 'description': 'The overall intravenous fentanyl consumption (microgram/ kilogram) during the surgery. The decision to administer fentanyl is guided by the changes of blood pressure and/ or heart rate greater than 20% from baseline level.'}], 'secondaryOutcomes': [{'measure': 'systolic blood pressure change', 'timeFrame': 'within 5 minutes after skull pin insertion', 'description': 'The maximal systolic blood pressure within the first 5 minutes after skull pin insertion will be recorded.\n\nThe systolic blood pressure change from baseline will be calculated. The unit is mmHg.'}, {'measure': 'Heart rate change', 'timeFrame': 'within 5 minutes after skull pin insertion', 'description': 'The maximal heart rate within the first 5 minutes after skull pin insertion will be recorded.\n\nThe heart rate change from baseline level will be calculated. The unit is beats per minute.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['supratentorial brain tumour', 'craniotomy'], 'conditions': ['Brain Tumour']}, 'descriptionModule': {'briefSummary': 'Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).', 'detailedDescription': 'Anterior scalp block with 0.5% plain Marcaine 20 ml. may reduce the intraoperative opioid consumption in neurosurgical patients who undergoing the supratentorial craniotomy compared to those who receive 0.9% normal saline solution (placebo).\n\nA Prospective Randomized Double Blind Control'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who have supratentorial brain tumor\n2. Patients have been scheduled to undergo an elective craniotomy to remove tumor in any surgical position\n3. Patients have been general anesthetized with endotracheal intubation and control ventilation\n4. Patients who have provided consent for the participation in the research and for the use of their medical record in research\n\nExclusion Criteria:\n\n1. Pregnant patients\n2. Patients who have a history of local anesthetic allergy and/ or anaphylaxis'}, 'identificationModule': {'nctId': 'NCT02057367', 'briefTitle': 'Scalp Nerve Block and Opioid Consumption in Brain Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Chiang Mai University'}, 'officialTitle': 'The Effect of Pre-incisional Anterior Scalp Block on Intraoperative Opioid Consumption in Adult Patients Undergoing Elective Craniotomy to Remove Tumor: A Prospective Randomized Controlled', 'orgStudyIdInfo': {'id': 'ANE2556-01510'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Scalp block with 0.5% plain marcaine', 'description': 'Anterior scalp block with 0.5% plain Marcaine 20 ml.', 'interventionNames': ['Drug: Scalp block with 0.5% plain Marcaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Scalp block with 0.9% normal saline', 'description': 'Anterior scalp block with 0.9% normal saline 20 ml.', 'interventionNames': ['Drug: Scalp block with 0.9% normal saline']}], 'interventions': [{'name': 'Scalp block with 0.5% plain Marcaine', 'type': 'DRUG', 'otherNames': ['Code 1'], 'description': 'Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.', 'armGroupLabels': ['Scalp block with 0.5% plain marcaine']}, {'name': 'Scalp block with 0.9% normal saline', 'type': 'DRUG', 'otherNames': ['Code 2'], 'description': 'Anterior scalp block will be done by using 0.9% normal saline 20 ml.', 'armGroupLabels': ['Scalp block with 0.9% normal saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50200', 'city': 'Chiang Mai', 'state': 'Chiang Mai', 'country': 'Thailand', 'facility': 'Chiang Mai University', 'geoPoint': {'lat': 18.79038, 'lon': 98.98468}}], 'overallOfficials': [{'name': 'Pathomporn Pin-on, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chiang Mai University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chiang Mai University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Anesthesiology', 'investigatorFullName': 'Pathomporn Pin on, M.D.', 'investigatorAffiliation': 'Chiang Mai University'}}}}