Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2026-01-01 @ 12:46 AM
Study NCT ID:
NCT01054469
Status:
COMPLETED
Last Update Posted:
2012-06-21
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominus Plane Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'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', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-20', 'studyFirstSubmitDate': '2010-01-20', 'studyFirstSubmitQcDate': '2010-01-20', 'lastUpdatePostDateStruct': {'date': '2012-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine if TAP block is a viable alternative to PCA narcotics for the control of pain after hand-assisted, laparoscopic nephrectomy.', 'timeFrame': '24 hours postoperatively'}], 'secondaryOutcomes': [{'measure': 'TAP block with ropivacaine will lead to equivalent or better results with regard to the following outcomes:pain scores, nausea, vomiting, sedation, request for PCA, discontinuation of Foley catheter, discharge from the hospital', 'timeFrame': '24 hours postoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['nephrectomy'], 'conditions': ['Nephrectomy']}, 'descriptionModule': {'briefSummary': 'Transversus Abdominus Plane (TAP) block may reduce need for postoperative pain medications in patients undergoing laparoscopic hand assisted nephrectomy. Our hypothesis is that the TAP block will result in a significant reduction in pain scores and morphine requirements in the active group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are ≥ 18 and ≤ 80 years of age.\n* Patients scheduled to undergo hand assisted laparoscopic removal of a single kidney for either tumor or living donor transplantation.\n\nExclusion Criteria:\n\n* Patients scheduled to undergo an open procedure for nephrectomy\n* Patients who are converted from hand assisted laparoscopic surgery to open surgery due to intraoperative complications.\n* Bilateral nephrectomy\n* Pregnant or lactating patients\n* Patients unable or unwilling to provide informed consent\n* Patients unable to comprehend the use of a visual analog scale\n* Patients desiring preemptive antiemetics\n* Opioid tolerance\n* Allergy to amide local anesthetics or any of the study drugs (morphine).\n* Contraindication to regional nerve block (bleeding disorder, infection at site of block)\n* Patients with history of dementia'}, 'identificationModule': {'nctId': 'NCT01054469', 'briefTitle': 'Transversus Abdominus Plane Block', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Ultrasound Guided Transversus Abdominus Plane Block for Patients Undergoing Laparoscopic Hand-assisted Nephrectomy.', 'orgStudyIdInfo': {'id': '08-003563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'TAP block with placebo', 'interventionNames': ['Procedure: TAP block placement with placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block with ropivacaine', 'interventionNames': ['Procedure: Placement of block with ropivacaine']}], 'interventions': [{'name': 'TAP block placement with placebo', 'type': 'PROCEDURE', 'description': '20 ml of normal saline (placebo)', 'armGroupLabels': ['TAP block with placebo']}, {'name': 'Placement of block with ropivacaine', 'type': 'PROCEDURE', 'description': '20 ml of 0.5% ropivacaine hydrochloride', 'armGroupLabels': ['TAP block with ropivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32224', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'overallOfficials': [{'name': 'Stephen Aniskevich, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Stephen Aniskevich, III, MD', 'oldOrganization': 'Mayo Clinic'}}}}