Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2025-12-31 @ 5:53 AM
Study NCT ID:
NCT00905957
Status:
COMPLETED
Last Update Posted:
2022-06-03
First Post:
2009-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis Plane Block For Renal Transplant Recipients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-19', 'lastUpdatePostDateStruct': {'date': '2022-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption in first 24 hours after renal transplantation', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transversus abdominis plane block', 'relief'], 'conditions': ['Disorder Related to Renal Transplantation', 'Pain']}, 'referencesModule': {'references': [{'pmid': '24974901', 'type': 'DERIVED', 'citation': 'Gulyam Kuruba SM, Mukhtar K, Singh SK. A randomised controlled trial of ultrasound-guided transversus abdominis plane block for renal transplantation. Anaesthesia. 2014 Nov;69(11):1222-6. doi: 10.1111/anae.12704. Epub 2014 Jun 28.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of a local anaesthetic injection in the plane between the abdominal muscles in reducing the amount of pain relief required after surgery.', 'detailedDescription': 'The aim of this study is to evaluate the efficacy of transversus abdominis plane block in reducing the morphine requirements after renal transplantation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* renal transplant recipients\n* 18 to 75 years\n\nExclusion Criteria:\n\n* allergy to local anaesthetics\n* chronic pain\n* refusal'}, 'identificationModule': {'nctId': 'NCT00905957', 'briefTitle': 'Transversus Abdominis Plane Block For Renal Transplant Recipients', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Liverpool University Hospitals NHS Foundation Trust'}, 'officialTitle': 'Transversus Abdominis Plane Block For Renal Transplant Recipients: A Randomized Controlled Double-blinded Study', 'orgStudyIdInfo': {'id': '3818'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transversus abdominis plane (TAP) Group', 'description': 'Patients will receive a TAP block using a local anaesthetic agent after induction of anaesthesia', 'interventionNames': ['Procedure: TAP block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'Patients will receive a TAP block using a placebo after induction of anaesthesia', 'interventionNames': ['Procedure: TAP block with placebo']}], 'interventions': [{'name': 'TAP block', 'type': 'PROCEDURE', 'description': 'TAP block using 20 ml of a local anaesthetic agent will be used in the treatment group', 'armGroupLabels': ['Transversus abdominis plane (TAP) Group']}, {'name': 'TAP block with placebo', 'type': 'PROCEDURE', 'description': 'TAP block using a placebo after induction of anaesthesia', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L7 8XP', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Royal Liverpool and Broadgreen University Hospitals', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Liverpool University Hospitals NHS Foundation Trust', 'class': 'OTHER_GOV'}, 'responsibleParty': {'oldNameTitle': 'KARIM MUKHTAR', 'oldOrganization': 'ROYAL LIVERPOOL AND BROADGREEN UNIVERSITY HOSPITALS'}}}}