Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2026-01-08 @ 11:05 PM
Study NCT ID:
NCT02513433
Status:
COMPLETED
Last Update Posted:
2015-08-04
First Post:
2015-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000699', 'term': 'Pain Insensitivity, Congenital'}], 'ancestors': [{'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077554', 'term': 'Levobupivacaine'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-31', 'studyFirstSubmitDate': '2015-07-30', 'studyFirstSubmitQcDate': '2015-07-30', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Onset of sensory block', 'timeFrame': '30 minutes', 'description': 'Time to achieve sensory block up to tenth thoracic dermatome'}], 'secondaryOutcomes': [{'measure': 'Time for 2 segment regression of sensory block', 'timeFrame': '90 minutes', 'description': 'Time for regression of sensory block 2 segments lower than maximum blocked dermatome'}, {'measure': 'Time to achieve maximum motor block', 'timeFrame': '45 minutes', 'description': 'Time to achieve motor block of modified Bromage score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lumbar epidural anaesthesia'], 'conditions': ['Pain Insensitivity, Congenital']}, 'descriptionModule': {'briefSummary': 'This study compares the clinical efficacy of newer local anaesthetic drugs Levobupivacaine and Ropivacaine with Bupivacaine in lumbar epidural anaesthesia for hip surgeries.', 'detailedDescription': 'Some of the most common day care surgeries are hip surgeries, in which local anaesthetic agents can be used via epidural route for both intra-op and post-op analgesia.\n\nAmong the drugs used nowadays are Lignocaine, Bupivacaine, Levobupivacaine and Ropivacaine.However Bupivacaine usage is not free from side effects.\n\nThe claimed benefits of both Levobupivacaine and Ropivacaine are reduced cardiac toxicity on overdose and more specific effects on sensory rather than motor nerve fibres.\n\nRopivacaine, an analog of Mepivacaine, is one of the long acting amide anaesthetic agent similar to Bupivacaine in chemical structure and anaesthetic function. It is a first enantiomer-specific compound, which has a reduced risk of cardio toxicity, neuro toxicity and rapid recovery of motor function. Levobupivacaine is the pure S (-)-enantiomer of Bupivacaine, and in recent year has emerged as a safer alternative for regional anaesthesia than its racemic parent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA Grade I and II patients of either sex\n* Age 18-60 years\n* Undergoing various hip surgeries under lumbar epidural anesthesia\n\nExclusion Criteria:\n\n* Refusal for epidural\n* ASA-III\\&IV\n* Head injury\n* Psychiatric disease\n* Known allergic to test drugs\n* Major systemic disease\n* Any analgesia with in past 24 hours'}, 'identificationModule': {'nctId': 'NCT02513433', 'briefTitle': 'Comparison of Levobupivacaine, Ropivacaine and Bupivacaine in Epidural Anaesthesia', 'organization': {'class': 'OTHER', 'fullName': 'Government Medical College, Haldwani'}, 'officialTitle': 'Comparative Evaluation of Newer Congeners i.e. Levobupivacaine and Ropivacaine With Bupivacaine, in Lumbar Epidural Anaesthesia for Hip Surgeries', 'orgStudyIdInfo': {'id': '65/IEC/01/12-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine & Levobupivacaine', 'description': 'Bupivacaine 15 ml 0.5% and Levobupivacaine 15 ml 0.5% in epidural route before surgery', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Levobupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine & Ropivacaine', 'description': 'Bupivacaine 15 ml 0.5% and Ropivacaine 15 ml 0.75% in epidural route before surgery', 'interventionNames': ['Drug: Bupivacaine', 'Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine & Levobupivacaine', 'description': 'Ropivacaine 15 ml 0.75% and Levobupivacaine 15 ml 0.5% in epidural route before surgery', 'interventionNames': ['Drug: Levobupivacaine', 'Drug: Ropivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Anawin', 'Sensorcaine'], 'description': 'Local anesthetic', 'armGroupLabels': ['Bupivacaine & Levobupivacaine', 'Bupivacaine & Ropivacaine']}, {'name': 'Levobupivacaine', 'type': 'DRUG', 'otherNames': ['Levo-anawin'], 'description': 'Local anesthetic', 'armGroupLabels': ['Bupivacaine & Levobupivacaine', 'Ropivacaine & Levobupivacaine']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'otherNames': ['Ropin'], 'description': 'Local anesthetic', 'armGroupLabels': ['Bupivacaine & Ropivacaine', 'Ropivacaine & Levobupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '263139', 'city': 'Haldwani', 'state': 'Uttarakhand', 'country': 'India', 'facility': 'Government Medical College', 'geoPoint': {'lat': 29.22254, 'lon': 79.5286}}], 'overallOfficials': [{'name': 'Geeta Bhandari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor and Head of the department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Government Medical College, Haldwani', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Dr Subhro Mitra', 'investigatorAffiliation': 'Government Medical College, Haldwani'}}}}