Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 4:35 AM
Study NCT ID:
NCT01349751
Status:
COMPLETED
Last Update Posted:
2013-11-07
First Post:
2011-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-05', 'studyFirstSubmitDate': '2011-05-05', 'studyFirstSubmitQcDate': '2011-05-06', 'lastUpdatePostDateStruct': {'date': '2013-11-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time to T4-dermatome sensory blockade', 'timeFrame': '30 minutes', 'description': 'to investigate specific blocking characteristics of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery'}], 'secondaryOutcomes': [{'measure': 'side effects', 'timeFrame': '1 to 4 hours intraoperation plus within 2 hours in the recovery room', 'description': 'to investigate side effects of intrathecal hyperbaric levobupivacaine compared with isobaric levobupivacaine for gynaecologic surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['abdominal incision', 'hyperbaric', 'isobaric', 'levobupivacaine', 'spinal anaesthesia'], 'conditions': ['Observation of Neuromuscular Block', 'Disease (or Disorder); Gynecological']}, 'descriptionModule': {'briefSummary': 'The authors would like to investigate the blocking characteristics, surgical quality and side effects of intrathecal levobupivacaine whether there are any differences between the hyperbaric and the isobaric formulation for gynaecologic surgeries which need higher block level than the urological surgeries.', 'detailedDescription': 'The investigators study in the similar patients, give the same intervention except the baricity of levobupivacaine. The investigators record the level of sensory block and modified Bromage score for motor blockade.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-III, aged 18-70 yr, scheduled for elective gynaecologic surgery, (total abdominal hysterectomy (TAH), TAH with uni-/bilateral salpingo-oophorectomy (SO), uni-/bilateral ovarian cystectomy, or myomectomy\n\nExclusion Criteria:\n\n* contraindications for spinal block, body mass index (BMI) more than 35 kg/m2 and height less than 150 cm'}, 'identificationModule': {'nctId': 'NCT01349751', 'briefTitle': 'Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Clinical Characteristics of Spinal Levobupivacaine: Hyperbaric Compared With Isobaric Solution', 'orgStudyIdInfo': {'id': 'SiEC 197/2549'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'isobaric levobupivacaine', 'description': 'spinal isobaric levobupivacaine', 'interventionNames': ['Drug: isobaric levobupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'hyperbaric levobupivacaine', 'description': 'hyperbaric levobupivacaine', 'interventionNames': ['Drug: hyperbaric levobupivacaine']}], 'interventions': [{'name': 'isobaric levobupivacaine', 'type': 'DRUG', 'otherNames': ['Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway'], 'description': '0.42% either isobaric levobupivacaine 3 ml spinal injection once', 'armGroupLabels': ['isobaric levobupivacaine']}, {'name': 'hyperbaric levobupivacaine', 'type': 'DRUG', 'otherNames': ['Chirocaine, Abbott Laboratories, Nycomed Pharma AS, Norway'], 'description': '0.42% hyperbaric levobupivacaine 3 ml spinal injection once', 'armGroupLabels': ['hyperbaric levobupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Vimolluck - Sanansilp, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dept of Anesthesiology, Faculty of Medicine Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Vimolluck Sanansilp', 'investigatorAffiliation': 'Mahidol University'}}}}