Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2026-01-04 @ 12:42 AM
Study NCT ID:
NCT01245868
Status:
COMPLETED
Last Update Posted:
2015-05-08
First Post:
2010-06-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-07', 'studyFirstSubmitDate': '2010-06-14', 'studyFirstSubmitQcDate': '2010-11-22', 'lastUpdatePostDateStruct': {'date': '2015-05-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of spinal blockade', 'timeFrame': 'Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes.'}], 'secondaryOutcomes': [{'measure': 'Time to fulfillment of discharge criteria from the hospital.', 'timeFrame': 'Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Spinal anaesthesia', 'Bupivacaine', 'Lidocaine', 'Duration of blockade'], 'conditions': ['Spinal Anesthesia']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The patient want spinal anaesthesia\n* No contradictions against spinal anaesthesia\n* Healthy people (ASA-score 1 or 2)\n* Body mass index \\< 35 and between 155 and 190 cm\n\nExclusion Criteria:\n\n* Known allergic reactions to planned drugs\n* Neurologic disturbances\n* Diabetes'}, 'identificationModule': {'nctId': 'NCT01245868', 'briefTitle': 'Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine', 'organization': {'class': 'OTHER', 'fullName': 'Frederikssunds Hospital, Denmark'}, 'officialTitle': 'Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine?', 'orgStudyIdInfo': {'id': 'FRS-AN2009-03-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bupivacaine', 'description': 'Bupivacaine as used routinely', 'interventionNames': ['Drug: bupivacaine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Lidocaine added to bupivacaine', 'description': 'lidocaine is added to bupivacaine', 'interventionNames': ['Drug: Lidocaine', 'Drug: bupivacaine']}], 'interventions': [{'name': 'Lidocaine', 'type': 'DRUG', 'armGroupLabels': ['Lidocaine added to bupivacaine']}, {'name': 'bupivacaine', 'type': 'DRUG', 'armGroupLabels': ['Bupivacaine', 'Lidocaine added to bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3600', 'city': 'Frederikssund', 'country': 'Denmark', 'facility': 'Dep. of anesthesiology, Hospital of Frederikssund', 'geoPoint': {'lat': 55.83956, 'lon': 12.06896}}, {'zip': 'DK 3600', 'city': 'Frederikssund', 'country': 'Denmark', 'facility': 'Jon Jacobsen', 'geoPoint': {'lat': 55.83956, 'lon': 12.06896}}], 'overallOfficials': [{'name': 'Jon Jacobsen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Frederikssunds Hospital, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Frederikssunds Hospital, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief consultant', 'investigatorFullName': 'Jon Jacobsen', 'investigatorAffiliation': 'Frederikssunds Hospital, Denmark'}}}}