Ignite Creation Date:
2025-12-24 @ 3:24 PM
Ignite Modification Date:
2026-06-25 @ 1:34 AM
Study NCT ID:
NCT02987192
Status:
UNKNOWN
Last Update Posted:
2017-07-05
First Post:
2016-11-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2019-04-09', 'releaseDate': '2019-01-07'}], 'estimatedResultsFirstSubmitDate': '2019-01-07'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-01', 'studyFirstSubmitDate': '2016-11-16', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analogue score of post-dural puncture headache', 'timeFrame': '1 to 7 days after operation'}], 'secondaryOutcomes': [{'measure': 'Visual analogue score of low back pain', 'timeFrame': '1 to 7 days after operation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'anticoagulation', 'minimally invasive', 'Cesarean Section', 'Maternal'], 'conditions': ['Anticoagulation', 'Minimally Invasive', 'Spinal Anesthesia']}, 'referencesModule': {'references': [{'pmid': '30636632', 'type': 'DERIVED', 'citation': 'Huang D, Zhu L, Chen J, Zhou J. Minimally invasive spinal anesthesia for cesarean section in maternal anticoagulation therapy: a randomized controlled trial. BMC Anesthesiol. 2019 Jan 12;19(1):11. doi: 10.1186/s12871-018-0679-1.'}]}, 'descriptionModule': {'briefSummary': 'Spinal canal anesthesia is marked the most commonly used method of cesarean section. Traditional spinal anesthesia may cause post-dural puncture headache and low back pain.Plenty of parturients are undergoing anticoagulation therapy.They may be forced to accept general anesthesia in order to avoid epidural hematoma.Therefore, we propose minimally invasive spinal anesthesia.', 'detailedDescription': 'Traditional group patients will receive cutting type 22 gauge needles, while minimally invasive group patients will receive pen type 27 gauge needles.Patients will be blinded to the intervention allocations. Spinal anesthesia will be performed with a standardized technique. Lumbar puncture will be performed through an interspace (L3-4 or L2-3) with patients in a lateral decubitus position. After free flow of cerebrospinal fluid through the needle tip be verified, 2ml ropivacaine will be injected. We will record puncture situation, anesthesia plane and measure post-dural puncture headache, post-operative back pain and epidural hematoma.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. puerpera accept anticoagulation therapy\n2. American society of anesthesiologists(ASA) classification I to II level\n3. Willing to participate in this study and signed an informed consent\n4. pregnancy at least 37 weeks\n\nExclusion Criteria:\n\n1. platelet count less than 50\\*100000000\n2. International Normalized Ratio more than 1.5\n3. site of puncture with infection\n4. with intracranial hypertension\n5. with lumbar spine or spinal cord disorders'}, 'identificationModule': {'nctId': 'NCT02987192', 'briefTitle': 'Minimally Invasive Lumbar Aneasthesia Used for Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Comparison of the Impact Between Minimally Invasive and Traditional Spinal Anesthesia for Cesarean Section in Maternal Anticoagulation Therapy:Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MICS2016033'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'traditional group', 'description': 'Traditional group patients will receive cutting type 22 gauge needles', 'interventionNames': ['Device: cutting type 22 gauge needles']}, {'type': 'EXPERIMENTAL', 'label': 'minimally invasive group', 'description': 'minimally invasive group patients will receive pen type 27 gauge needles', 'interventionNames': ['Device: pen type 27 gauge needles']}], 'interventions': [{'name': 'pen type 27 gauge needles', 'type': 'DEVICE', 'description': 'minimally invasive group patients will receive pen type 27 gauge needles.', 'armGroupLabels': ['minimally invasive group']}, {'name': 'cutting type 22 gauge needles', 'type': 'DEVICE', 'description': 'traditional group patients will receive cutting type 22 gauge needles.', 'armGroupLabels': ['traditional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'DAN HUANG, MS', 'role': 'CONTACT', 'email': 'huangdan363@163.com', 'phone': '15921108822'}, {'name': 'JIE ZHOU, MS', 'role': 'CONTACT', 'email': 'zhoujie1486@renji.com', 'phone': '13601693227'}, {'name': 'DAN HUANG, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Renji Hospital, Shanghai Jiao Tong University, School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'DAN HUANG, MS', 'role': 'CONTACT', 'email': 'huangdan363@163.com', 'phone': '15921108822'}, {'name': 'JIE ZHOU, MS', 'role': 'CONTACT', 'email': 'zhoujie1486@renji.com', 'phone': '13601693227'}], 'overallOfficials': [{'name': 'WEIFENG YU, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Anesthesiology Department Renji Hospital, Shanghai Jiao Tong University, School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'DAN HUANG', 'investigatorAffiliation': 'RenJi Hospital'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2019-01-07', 'type': 'RELEASE'}, {'date': '2019-04-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'DAN HUANG, Dr., RenJi Hospital'}}}}