Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:41 AM
Study NCT ID:
NCT06256302
Status:
COMPLETED
Last Update Posted:
2024-07-25
First Post:
2024-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy
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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-24', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-12', 'lastUpdatePostDateStruct': {'date': '2024-07-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain score', 'timeFrame': '24 hours of surgery.', 'description': 'Pain score will be evaluated through Visual analogue scale (VAS) score of 0-10cms.'}], 'secondaryOutcomes': [{'measure': 'Analgesia consumption', 'timeFrame': 'During 24 hours of surgery', 'description': 'Patients will be given analgesics only on complain of pain of VAS score of 4 and above.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'To compare the transverses abdominis plane block outcome versus local wound infiltration for postoperative analgesia in patients undergoing total abdominal hysterectomy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range 18 to 50 years\n* Female\n* ASA I \\& II\n* Undergoing Abdominal Hysterectomy under General anaesthesia\n\nExclusion Criteria:\n\n* Hepatic failure (assessed on clinical signs and symptoms, elevated liver enzymes and ultrasound findings showing loss of normal texture of liver) or renal failure (a GFR of 15 or less)\n* Allergy or contraindication to study drugs on history\n* Drug abuse or addiction\n* Bleeding tendency'}, 'identificationModule': {'nctId': 'NCT06256302', 'briefTitle': 'Transverses Abdominis Plane Block Versus Local Wound Infiltration in Total Abdominal Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ziauddin University'}, 'officialTitle': 'Transverses Abdominis Plane Block Versus Local Wound Infiltration for Postoperative Pain Management in Patients Undergoing Total Abdominal Hysterectomy', 'orgStudyIdInfo': {'id': '7861023MAANE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Transverses abdominis plane block', 'interventionNames': ['Procedure: Transverses Abdominis Plane Block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Local wound infiltration', 'interventionNames': ['Procedure: Local wound infiltration']}], 'interventions': [{'name': 'Transverses Abdominis Plane Block', 'type': 'PROCEDURE', 'description': 'Transverses abdominis plane block will be provided randomly using prospective double-blinding.', 'armGroupLabels': ['Transverses abdominis plane block']}, {'name': 'Local wound infiltration', 'type': 'PROCEDURE', 'description': 'Local wound infiltration will be provided randomly using prospective double-blinding.', 'armGroupLabels': ['Local wound infiltration']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Muhammad Arif', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Muhammad Arif', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ziauddin University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr Muhammad Arif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr Muhammad Arif', 'investigatorAffiliation': 'Ziauddin University'}}}}