Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-30 @ 7:49 PM
Study NCT ID:
NCT00587704
Status:
COMPLETED
Last Update Posted:
2010-02-23
First Post:
2007-12-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-02-22', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2008-01-04', 'lastUpdatePostDateStruct': {'date': '2010-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Successful full block at T11-L1', 'timeFrame': 'Every 10 minutes until full block achieved'}]}, 'conditionsModule': {'conditions': ['Inguinal Hernia']}, 'descriptionModule': {'briefSummary': 'Primary aim:\n\n1\\. To compare the nerve stimulation vs. anatomic techniques of paravertebral block of T11-L1 in providing surgical anesthesia for patients undergoing inguinal hernia repair.\n\nSecondary aims:\n\n1. Compare VAS pain scores in the two groups of patients over the first 24 hours.\n2. Compare opioid intake over the first 24 hours in the two groups of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unilateral open inguinal herniorrhaphy\n* Patient must be \\>18 years of age\n* ASA physical status of I, II, or III\n* Patient competent to provide informed consent\n\nExclusion Criteria:\n\n* Patient \\< 18 years of age\n* Pregnant or lactating women\n* Patient unwilling or unable to provide informed consent\n* Contraindications to regional anesthesia\n* Allergy to amide local anesthetics'}, 'identificationModule': {'nctId': 'NCT00587704', 'acronym': 'PVB', 'briefTitle': 'Paravertebral Blocks: Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks in Inguinal Hernia Repair', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Paravertebral Blocks Techniques: A Pilot Study to Compare Nerve Stimulation vs. Anatomic Landmarks for Patients Undergoing Inguinal Hernia Repair', 'orgStudyIdInfo': {'id': '07-002759'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Nerve Stimulation', 'description': 'Use of nerve stimulator for placement of PVB nerve block', 'interventionNames': ['Procedure: PVB using nerve stimulation']}, {'type': 'OTHER', 'label': 'Anatomic landmarks', 'description': 'Use of anatomic landmarks for placement of PVB block', 'interventionNames': ['Procedure: PVB using anatomic landmarks']}], 'interventions': [{'name': 'PVB using nerve stimulation', 'type': 'PROCEDURE', 'description': '5ml of 1% ropivacaine injected incrementally', 'armGroupLabels': ['Nerve Stimulation']}, {'name': 'PVB using anatomic landmarks', 'type': 'PROCEDURE', 'description': '5ml of 1% ropivacaine injected incrementally', 'armGroupLabels': ['Anatomic landmarks']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Steven R. Clendenen, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Steven R. Clendenen, M.D.', 'oldOrganization': 'Mayo Clinic'}}}}