Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2025-12-27 @ 11:43 PM
Study NCT ID:
NCT01548794
Status:
COMPLETED
Last Update Posted:
2015-04-22
First Post:
2012-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006552', 'term': 'Hernia, Inguinal'}], 'ancestors': [{'id': 'D046449', 'term': 'Hernia, Abdominal'}, {'id': 'D006547', 'term': 'Hernia'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000775', 'term': 'Anesthesia, Spinal'}, {'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000772', 'term': 'Anesthesia, Local'}, {'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-21', 'studyFirstSubmitDate': '2012-03-06', 'studyFirstSubmitQcDate': '2012-03-07', 'lastUpdatePostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of spinal block', 'timeFrame': 'day of surgery', 'description': 'Time between the onset of the sensorial block at L1 dermatome and the resolution of the sensorial block at S3 dermatome.'}], 'secondaryOutcomes': [{'measure': 'Discharge time', 'timeFrame': 'Day of surgery', 'description': 'The time between the end of surgery and home discharge.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'bupivacaine', 'lidocaine', 'local infiltration anesthesia', 'recovery', 'duration of anesthesia', 'outpatient herniorrhaphy'], 'conditions': ['Anesthesia', 'Inguinal Hernia']}, '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 purpose of this study is the investigation of whether adding lidocaine to hyperbaric bupivacaine could decrease the duration of bupivacaine spinal block and provide shorter recovery and discharge times than local infiltration anesthesia in outpatient herniorrhaphy procedures.', 'detailedDescription': 'Consecutive 93 patients undergoing inguinal herniorrhaphy will be recruited with a prospective protocol.Spinal anesthesia will be commenced in Group BLS with 2 ml hyperbaric bupivacaine (10 mg) + 0.6 ml 1 % lidocaine (6 mg), in Group BS, hyperbaric bupivacaine (10 mg) + saline in the same volume and Group LIA will have anesthesia with bupivacaine and lidocaine for step by step local anesthetic infiltration. Sensorial block will be measured with pinprick test, motor block will be tested with Bromage scale. Heart rate, blood pressure and peripheral oxygen saturation will be measured every 5 minutes. Time of subarachnoid injection, onset of sensorial block (block at L1 dermatome), time to block T10 dermatome, maximum block level, time to maximum block and time to two segment regression, T10 regression , LI regression and S1 regression of the block will be recorded in group BLS and BS.The onset and resolution of the sensorial and motor block will be assessed by anesthetists blinded to group allocation. PACU stay and discharge times and VAS pain scores will be recorded in all patients. Patients also will be investigated for adverse events (hypotension, bradycardia, nausea,PDPH, TNS, urinary retention)and satisfaction regarding the anesthetic method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having inguinal hernia\n* Not hypersensitive to study drugs\n* ASA classification I-III\n\nExclusion Criteria:\n\n* ASA classification IV-V\n* Contraindications for spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT01548794', 'briefTitle': 'Recovery of Bupivacaine or Bupivacaine-Lidocaine Spinal Anesthesia and Infiltration Anesthesia in Herniorrhaphy', 'organization': {'class': 'OTHER', 'fullName': 'Diskapi Teaching and Research Hospital'}, 'officialTitle': 'A Comparison of the Recovery Profiles of Bupivacaine or Bupivacaine Mixed With Lidocaine Spinal Anesthesia and Local Infiltration Anesthesia for Outpatient Herniorrhaphy', 'orgStudyIdInfo': {'id': 'DiskapiTRHDYAZICIOGLU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine(Group B)', 'description': 'spinal anesthesia', 'interventionNames': ['Procedure: spinal anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine+Lidocaine (Group BL)', 'description': 'spinal anesthesia', 'interventionNames': ['Procedure: spinal anesthesia']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local Infitration Anesthesia(Group LI)', 'description': 'local infiltration anesthesia', 'interventionNames': ['Procedure: infiltration anesthesia']}], 'interventions': [{'name': 'spinal anesthesia', 'type': 'PROCEDURE', 'otherNames': ['marcaine heavy'], 'description': 'To receive 2 ml heavy bupivacaine + 0,6 ml saline', 'armGroupLabels': ['Bupivacaine(Group B)']}, {'name': 'spinal anesthesia', 'type': 'PROCEDURE', 'otherNames': ['marcaine heavy', 'lidocaine'], 'description': 'To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.', 'armGroupLabels': ['Bupivacaine+Lidocaine (Group BL)']}, {'name': 'infiltration anesthesia', 'type': 'PROCEDURE', 'otherNames': ['marcaine', 'lidocaine'], 'description': 'To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.', 'armGroupLabels': ['Local Infitration Anesthesia(Group LI)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06610', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Diskapi Yildirim Beyazit Training and Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Dilek Yazicioglu', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Diskapi Teaching and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor Specialist in Anesthesiology Principal investigator', 'investigatorFullName': 'DILEK YAZICIOGLU', 'investigatorAffiliation': 'Diskapi Teaching and Research Hospital'}}}}