Ignite Creation Date:
2025-12-24 @ 9:39 PM
Ignite Modification Date:
2025-12-25 @ 7:21 PM
Study NCT ID:
NCT04344132
Status:
UNKNOWN
Last Update Posted:
2020-04-15
First Post:
2020-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015173', 'term': 'Supratentorial Neoplasms'}], 'ancestors': [{'id': 'D001932', 'term': 'Brain Neoplasms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-04-14', 'studyFirstSubmitDate': '2020-03-30', 'studyFirstSubmitQcDate': '2020-04-13', 'lastUpdatePostDateStruct': {'date': '2020-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analogue Scale score at 24 h after surgery', 'timeFrame': 'up to 24 hours', 'description': 'Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain),'}], 'secondaryOutcomes': [{'measure': 'Visual Analogue Scale score at 0', 'timeFrame': 'Baseline', 'description': 'Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Visual Analogue Scale score at 2 hours', 'timeFrame': 'up to 2 hours', 'description': 'Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Visual Analogue Scale score at 6 hours', 'timeFrame': 'up to 6 hours', 'description': 'Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'Visual Analogue Scale score at 12 hours', 'timeFrame': 'up to 12 hours', 'description': 'Visual Analogue Scale ranging from 0 (no pain) to 10 (worst imaginable pain)'}, {'measure': 'time first request of a patient for rescue analgesia', 'timeFrame': 'during surgery'}, {'measure': 'intraoperative anesthetics', 'timeFrame': 'during surgery time', 'description': '(and opioids consumption)'}, {'measure': 'awakening time', 'timeFrame': 'time from the end of surgery to awekening'}, {'measure': 'changes in hemodynamics at mayfiled headfraom positioning', 'timeFrame': 'surgery', 'description': 'changes in term of blood pressure'}, {'measure': 'changes in hemodynamics at mayfiled headfraom positioning', 'timeFrame': 'surgery', 'description': 'changes in heart rate'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Supratentorial Neoplasms']}, 'referencesModule': {'references': [{'pmid': '24492515', 'type': 'BACKGROUND', 'citation': 'Bebawy JF, Bilotta F, Koht A. A modified technique for auriculotemporal nerve blockade when performing selective scalp nerve block for craniotomy. J Neurosurg Anesthesiol. 2014 Jul;26(3):271-2. doi: 10.1097/ANA.0000000000000032. No abstract available.'}, {'pmid': '27996204', 'type': 'BACKGROUND', 'citation': 'Tsaousi GG, Logan SW, Bilotta F. Postoperative Pain Control Following Craniotomy: A Systematic Review of Recent Clinical Literature. Pain Pract. 2017 Sep;17(7):968-981. doi: 10.1111/papr.12548. Epub 2017 Feb 23.'}]}, 'descriptionModule': {'briefSummary': 'Study was designed to evaluate optimal timing for selective scalp block in patients undergoing general anesthesia for supratentorial craniotomy.Pain score assessed by visual analog scale (VAS) preoperatively (baseline) and after extubation at 2, 6, 12 and 24 hours; time first request of a patient for rescue analgesia; intraoperative anesthetics and opioids consumption; awakening time; perioperative complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients (\\>18 years),\n* presenting with supratentorial brain tumors scheduled for elective craniotomy under general anesthesia\n\nExclusion Criteria:\n\n* history of allergic reactions on local anesthetics;\n* ASA status ≥ 3;\n* depressed consciousness in pre- or postoperative period;\n* aphasia (as investigators were not able to obtain VAS score).'}, 'identificationModule': {'nctId': 'NCT04344132', 'briefTitle': 'Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Roma La Sapienza'}, 'officialTitle': 'Pre- vs. Postoperative Scalp Block for Pain Control After Supratentorial Craniotomy', 'orgStudyIdInfo': {'id': 'URom'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Scalp Block', 'type': 'PROCEDURE', 'description': 'standard practice of controll the pain after surgery. Block of the nerve emergences.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Roma La Sapienza', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Federico Bilotta', 'investigatorAffiliation': 'University of Roma La Sapienza'}}}}