Ignite Creation Date:
2025-12-25 @ 2:56 AM
Ignite Modification Date:
2026-03-03 @ 8:53 AM
Study NCT ID:
NCT02939833
Status:
UNKNOWN
Last Update Posted:
2016-10-20
First Post:
2016-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Scalp Nerve Blocks on Systemic Inflammation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008579', 'term': 'Meningioma'}], 'ancestors': [{'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009383', 'term': 'Neoplasms, Vascular Tissue'}, {'id': 'D008577', 'term': 'Meningeal Neoplasms'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2019-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-10-18', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-10-18', 'lastUpdatePostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum TNF-α level', 'timeFrame': '24 hour after surgery'}, {'measure': 'serum IL-6 level', 'timeFrame': '24 hour after surgery'}, {'measure': 'serum IL-1β level', 'timeFrame': '24 hour after surgery'}], 'secondaryOutcomes': [{'measure': 'serum TNF-α level', 'timeFrame': '1 hour after surgery'}, {'measure': 'serum IL-6 level', 'timeFrame': '1 hour after surgery'}, {'measure': 'serum IL-1β level', 'timeFrame': '1 hour after surgery'}, {'measure': 'serum TNF-α level', 'timeFrame': '72 hour after surgery'}, {'measure': 'serum IL-6 level', 'timeFrame': '72 hour after surgery'}, {'measure': 'serum IL-1β level', 'timeFrame': '72 hour after surgery'}, {'measure': 'VAS score', 'timeFrame': '24 hour after surgery'}, {'measure': 'VAS score', 'timeFrame': '48 hour after surgery'}, {'measure': 'VAS score', 'timeFrame': '72 hour after surgery'}, {'measure': 'dosage of pain-control medicine', 'timeFrame': 'within 72 hour after surgery'}, {'measure': 'NRS score', 'timeFrame': '24 hour after surgery'}, {'measure': 'NRS score', 'timeFrame': '48 hour after surgery'}, {'measure': 'NRS score', 'timeFrame': '72 hour after surgery'}, {'measure': 'incidence of intracranial infection', 'timeFrame': 'within 30 days after surgery'}, {'measure': 'Hospitalization Days', 'timeFrame': 'up to 30 days'}, {'measure': 'out of pocket expenditure for hospitalisation', 'timeFrame': 'hospital discharge/up to 30 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Meningiomas']}, 'descriptionModule': {'briefSummary': 'Patients undergoing meningeoma resection surgery will be randomly assigned to two groups. One group will receive scalp nerve blocks with 0.5% ropivacaine, whereas the other group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion. Serum levels of TNF-α、IL-6 and IL-1β will be measured and compared at before surgery, 1h, 24h and 72h after surgery, respectively. VAS score, dosage of pain-control medicine and NRS score at the first three days after surgery, ratio of intracranial infection within 30d after surgery, and total hospitalization days and medical expenditure will also be recorded and compared between the two groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 18-28 kg/m2 ASA Physical Status 1-2 diagnosed Meningeoma and will have selective Meningeoma Resection Surgery the incision will be conducted at the frontal, top or the temperal skull.\n\nExclusion Criteria:\n\n* previous brain surgery severe systemic disease (heart, lung, kidney, or immune system) nerval or mental disorders a history of addiction to opioids allergic to ropivacaine infection at block site or severe systemic infection refuse to attend the trial'}, 'identificationModule': {'nctId': 'NCT02939833', 'briefTitle': 'Effects of Scalp Nerve Blocks on Systemic Inflammation', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Effects of Scalp Nerve Blocks on Systemic Inflammation After Meningeoma Resection Surgery：a Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'NB20161010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ropivacaine', 'description': 'patients in this group will receive scalp nerve blocks with 0.5% ropivacaine after anesthesia induction and before skull-pin insertion', 'interventionNames': ['Procedure: Scalp Nerve Blocks With Ropivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'saline', 'description': 'patients in this group will receive scalp nerve blocks with 0.9% saline after anesthesia induction and before skull-pin insertion', 'interventionNames': ['Procedure: Scalp Nerve Blocks With Saline']}], 'interventions': [{'name': 'Scalp Nerve Blocks With Ropivacaine', 'type': 'PROCEDURE', 'armGroupLabels': ['ropivacaine']}, {'name': 'Scalp Nerve Blocks With Saline', 'type': 'PROCEDURE', 'armGroupLabels': ['saline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai Renji hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}