Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2025-12-27 @ 10:37 PM
Study NCT ID:
NCT01675895
Status:
COMPLETED
Last Update Posted:
2012-12-18
First Post:
2012-08-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011470', 'term': 'Prostatic Hyperplasia'}], 'ancestors': [{'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D008012', 'term': 'Lidocaine'}], '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'}, {'id': 'D000083', 'term': 'Acetanilides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-17', 'studyFirstSubmitDate': '2012-08-24', 'studyFirstSubmitQcDate': '2012-08-29', 'lastUpdatePostDateStruct': {'date': '2012-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'maximum block level', 'timeFrame': 'participants will be followed on the operation day', 'description': 'the dermatomal level that the sensorial block reached, determined with the pin prick test, expressed with dermatomes'}], 'primaryOutcomes': [{'measure': 'The duration of the spinal block (S1 regression of the block)', 'timeFrame': 'participanta will be followed on the operation day', 'description': 'the time between the intrathecal injection and sensorial block regression to S1 dermatome, measured in minutes'}], 'secondaryOutcomes': [{'measure': 'postoperative care unit stay', 'timeFrame': 'participants will be followed on the operation day', 'description': 'the time between the patient entered the PACU and left the PACU (when the sensorial block was regressed to S1 dermatome and the patient fulfilled an Aldrete score higher or equal to 9), measured in minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hyperbaric Levobupivacaine', 'İntrathecal', 'Lidocaine', 'TUR-P'], 'conditions': ['Benign Prostate Hyperplasia']}, 'referencesModule': {'references': [{'pmid': '18713891', 'type': 'BACKGROUND', 'citation': 'Lee SJ, Bai SJ, Lee JS, Kim WO, Shin YS, Lee KY. The duration of intrathecal bupivacaine mixed with lidocaine. Anesth Analg. 2008 Sep;107(3):824-7. doi: 10.1213/ane.0b013e3181806149.'}]}, 'descriptionModule': {'briefSummary': 'The main objective was to test the hypothesis that adding lidocaine to hyperbaric levobupivacaine could change the duration of levobupivacaine spinal block.', 'detailedDescription': 'A satisfactory spinal anaesthesia requires both a fast onset and proper duration at the same time. Transurethral resection of the prostate (TUR-P) is a surgery of medium duration. The addition of lidocaine to hyperbaric bupivacaine shortens the duration of bupivacaine spinal block and therefore provides more rapid recovery. This property of lidocaine is not verified with other local anesthetics. Levobupivacaine is a S-enantiomer of racemic bupivacaine and is a long acting local anesthetic.The aim of this prospective randomized controlled study was to investigate this effect of lidocaine, with a local anesthetic other than bupivacaine. It was hypothesized that the duration of the intrathecal block could change when performed with hyperbaric levobupivacaine mixed with low dose lidocaine and this technique could be consistent for the duration of TUR-P surgery. Participants will be followed on the day of surgery for primary and secondary outcome measures and 3 days postoperatively for complications (TNS).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective transurethral resection of the prostate (TUR-P)\n\nExclusion Criteria:\n\n* patients with contraindications for spinal anesthesia,\n* known sensitivity to the study drugs,\n* emergency cases, and\n* patients who refused spinal anaesthesia were excluded'}, 'identificationModule': {'nctId': 'NCT01675895', 'briefTitle': 'Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'Addition of Lidocaine to Levobupivacaine Reduces Intrathecal Block Duration: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'DİLEKLEVOBUPİVACAİNE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group Levobupivacaine lidocaine', 'description': 'Group Levobupivacaine lidocaine Spinal anesthesia with 1.5 ml hyperbaric levobupivacaine (6.75 mg) + 0.3 ml 2 % lidocaine', 'interventionNames': ['Drug: Levobupivacaine lidocaine spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group Control', 'description': 'Group Control levobupivacaine spinal anesthesia with levobupivacaine (6.75 mg) + saline', 'interventionNames': ['Drug: levobupivacaine Spinal anesthesia']}], 'interventions': [{'name': 'Levobupivacaine lidocaine spinal anesthesia', 'type': 'DRUG', 'otherNames': ['Chirocaine', 'Lidocaine'], 'description': 'Spinal anesthesia', 'armGroupLabels': ['Group Levobupivacaine lidocaine']}, {'name': 'levobupivacaine Spinal anesthesia', 'type': 'DRUG', 'otherNames': ['Chirocaine'], 'description': 'spinal anesthesia', 'armGroupLabels': ['Group Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Taylan Akkaya, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara Diskapi Yildirim Beyazit Teaching and Research Hospital, Turkey.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'DILEK YAZICIOGLU', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}