Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT06267820
Status:
COMPLETED
Last Update Posted:
2024-06-26
First Post:
2023-12-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D020910', 'term': 'Ketorolac'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007213', 'term': 'Indomethacin'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-22', 'studyFirstSubmitDate': '2023-12-13', 'studyFirstSubmitQcDate': '2024-02-15', 'lastUpdatePostDateStruct': {'date': '2024-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1st analgesic requirement', 'timeFrame': '24 hours', 'description': 'the time at which the 1st need for analgesia is given.'}, {'measure': 'Number of patients who requested analgesia', 'timeFrame': '24 hours', 'description': 'Number (percentage)of patients who requested analgesia'}], 'secondaryOutcomes': [{'measure': 'heart rate', 'timeFrame': '24 hours', 'description': 'the patient vital sign (beats/min)'}, {'measure': 'Total rescue analgesia', 'timeFrame': '24 hours', 'description': 'Total rescue analgesia in the first 24 h. postoperatively'}, {'measure': 'Satisfaction of the parents regarding their children analgesia', 'timeFrame': '24 hours', 'description': 'using 5- point satisfaction scale (1= Very satisfied, 2=Satisfied,3= Neither satisfied nor dissatisfied,4= Dissatisfied, 5= Very dissatisfied).\n\nThis satisfaction will be done by parents according to the VAS, incidence of side effects and analgesic requirements'}, {'measure': 'Number of children in each group who required analgesia in the first 24 h postoperatively', 'timeFrame': '24 hours', 'description': 'Number of children in each group who required analgesia in the first 24h postoperatively'}, {'measure': 'blood pressure', 'timeFrame': '24 hours', 'description': 'The patients blood pressure (mmHg)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['TAP', 'ketorolac', 'bupivacaine,', 'ultrasound', 'children'], 'conditions': ['Postoperative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Control of of pain in children is fundamental. TAP block is associated with less side effects compared with other neuraxial techniques especially when done under ultrasound guidance.\n\nKetorolac has analgesic effect comparable to morphine. Children were arranged randomly into two equal groups, forty-five children in each.\n\nGroup (K) (n= 45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).\n\nGroup (T) (n =45): received ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg)', 'detailedDescription': "This prospective randomized controlled study were carried out in Sohag university hospitals after getting approval from medical research ethics committee and written informed consents from the patients' parents or legal guardians. This study included 90 ASA status I and II children aged 6-12 years undergoing elective lower abdominal surgeries.Preoperative assessment:\n\n* History taking from the parents.\n* Complete physical examination.\n* Laboratory investigations: Complete Blood Picture and coagulation profile. Preoperative preparation\n\nBefore starting, standard monitoring will be as follow:\n\n1. Non-invasive blood pressure (systolic and diastolic).\n2. Peripheral Oxygen saturation (SpO2%). After insertion of intravenous line, all children will receive atropine premedication (0.01-0.02 mg/kg). General anesthesia will be induced using propofol 1% (2 mg/kg), atracurium (0.5 mg/kg) to facilitate endotracheal intubation. Anesthesia will be maintained using isoflurane (1-2%) with controlled ventilation.At the end of operation, muscle relaxant is reversed using neostigmine and atropine.\n\nIntraoperative hemodynamic parameters will be recorded throughout the surgery at fixed intervals (at time of skin incision then after every 5 min till the end of surgery).\n\nThen TAP block were done under ultrasound guidance using either bupivacaine and ketorolac or bupivacaine alone"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ASA status I and II children Age 6-12 years Elective lower abdominal surgeries.\n\nExclusion Criteria:\n\n* Parents' or legal guardians' refusal.\n* A history of developmental delay or mental retardation.\n* ASA III and IV.\n* A known allergy to ketorolac or bupivacaine.\n* Hemodynamic unstable patient\n* Urgent surgeries"}, 'identificationModule': {'nctId': 'NCT06267820', 'briefTitle': 'Combined Ketorolac Bupivacaine Versus Bupivacaine Alone for TAP Block in Children Undergoing Lower Abdominal Surgeries', 'organization': {'class': 'OTHER', 'fullName': 'Sohag University'}, 'officialTitle': 'A Comparative Study Between Combined Ketorolac Bupivacaine and Bupivacaine Alone for Transversus Abdominis Plane Block in Children Undergoing Lower Abdominal Surgeries: A Prospective Double- Blind Randomized Clinical Trial', 'orgStudyIdInfo': {'id': '2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block with bupivacaine and ketorolac', 'description': 'Ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg) and ketorolac (0.5 mg/kg).', 'interventionNames': ['Drug: Bupivacain', 'Drug: Ketorolac']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block with bupivacaine', 'description': 'ultrasound guided TAP block with bupivacaine 0.25% (0.5 ml/kg).', 'interventionNames': ['Drug: Bupivacain']}], 'interventions': [{'name': 'Bupivacain', 'type': 'DRUG', 'otherNames': ['bupivacaine'], 'description': 'analgesia', 'armGroupLabels': ['TAP block with bupivacaine', 'TAP block with bupivacaine and ketorolac']}, {'name': 'Ketorolac', 'type': 'DRUG', 'description': 'analgesia', 'armGroupLabels': ['TAP block with bupivacaine and ketorolac']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52514', 'city': 'Sohag', 'country': 'Egypt', 'facility': 'Fouad Ibrahim Soliman', 'geoPoint': {'lat': 26.55695, 'lon': 31.69478}}], 'overallOfficials': [{'name': 'Fouad I Soliman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sohag University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sohag University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesia and ICU', 'investigatorFullName': 'Fouad Soliman', 'investigatorAffiliation': 'Sohag University'}}}}