Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2025-12-31 @ 8:35 AM
Study NCT ID:
NCT05946733
Status:
COMPLETED
Last Update Posted:
2024-01-26
First Post:
2023-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomly divided into three equal groups using SPSS. Group A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. GroupC:will receive postoperative morphine by patient-controlled analgesia (PCA).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-24', 'studyFirstSubmitDate': '2023-06-17', 'studyFirstSubmitQcDate': '2023-07-13', 'lastUpdatePostDateStruct': {'date': '2024-01-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'opioid consumption', 'timeFrame': '48 hours', 'description': 'milligrams'}], 'secondaryOutcomes': [{'measure': 'patient satisfaction', 'timeFrame': '48 hours', 'description': 'visual analogue scale ((a scale from 0 to 10 where 0 is interpreted as no pain, 1-4 mild pain, 5-6 moderate pain, 7-10 severe pain)'}, {'measure': 'anesthesia recovery time', 'timeFrame': '1hour', 'description': 'minutes'}, {'measure': 'total perioperative analgesics requirements', 'timeFrame': '24 hours', 'description': 'milligrams'}, {'measure': 'Post-operative anaesthetic care unit (PACU) stay', 'timeFrame': '2 hours', 'description': 'minutes'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Use']}, 'descriptionModule': {'briefSummary': 'the investigators will compare the effect of pre-operative oblique subcostal TAP and lateral TAP blocks on the total perioperative opioids consumption for patients undergoing elective laparoscopic cholecystectomy', 'detailedDescription': "General anesthesia induction will be achieved using a sleeping dose of fentanyl 1µg/kg intravascular(IV), propofol 2mg/kg (IV), and atracurium 0.5mg/kg (IV) to facilitate tracheal intubation. General anesthesia will be maintained with lungs ventilation by pressure controlled mode with isoflurane\n\nDuring anesthesia maintenance Intraoperatively, if blood pressure BP or heart rate (HR) increase more than 20% from baseline, intravenous morphine (3- 5mg) will be given to stabilize the patients' haemodynamics. Fifteen minutes before the end of surgery all patients will receive 1g intravenous paracetamol and 4 grams ondansetron.\n\nPatients will be randomly divided into three equal groups:\n\nGroup A: will receive bilateral oblique subcostal TAP block Group B: will receive bilateral lateral TAP block. Group C :will receive postoperative morphine by patient-controlled analgesia (PCA)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible patients will be older than 21 years old with American society of anaesthesia physical status I\\& II scheduled for elective laparoscopic cholecystectomy.\n\nExclusion Criteria:\n\n* \\- Uncooperative.\n* Patients who have allergy to any of the study drugs.\n* Patients who are on opioids.\n* Known abuse of alcohol or medication.\n* Local infection at the site of injection or systemic infection.\n* Pregnancy.\n* Patients with coagulation disorders or on anticoagulation therapy.'}, 'identificationModule': {'nctId': 'NCT05946733', 'acronym': 'TAP', 'briefTitle': 'Two Approaches of Transversus Abdominis Block (TAP ) in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Comparison Between The Analgesic Effect of Oblique Subcostal and Lateral Approach of Ultrasound-Guided Transverse Abdominis Blocks for Patients Undergoing Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '11/2022ANET10-26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'subcostal TAP block', 'interventionNames': ['Procedure: Group A']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'lateral TAP block.', 'interventionNames': ['Procedure: Group B']}, {'type': 'OTHER', 'label': 'GroupC', 'description': 'will receive postoperative morphine by patient-controlled analgesia (PCA).', 'interventionNames': ['Other: Group C']}], 'interventions': [{'name': 'Group A', 'type': 'PROCEDURE', 'description': 'After induction of general anesthesia, oblique subcostal TAP blocks will be done(14) under the guidance of Sonosite ,superficial probe ,14-15 MHz ultrasound transducer', 'armGroupLabels': ['Group A']}, {'name': 'Group B', 'type': 'PROCEDURE', 'description': 'After induction of general anesthesia, bilateral lateral TAP block will be performed (15) under ultrasonographic guidance with transportable ultrasound device ( Sonosite ,superficial probe ,14-15 MHz)', 'armGroupLabels': ['Group B']}, {'name': 'Group C', 'type': 'OTHER', 'description': 'the analgesia will be maintained using a morphine patient-controlled analgesia (PCA) device set to give 1.5 mg bolus administration of morphine without a basic rate and 15 min lock-out time. The total amount of morphine administration will be recorded for the subsequent 24 h', 'armGroupLabels': ['GroupC']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Shibin Elkom', 'country': 'Egypt', 'facility': 'Menoufia University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'AMAL G SAFAN, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Menoufia University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Anesthesiology, Intensive Care and Pain Management Faculty of Medicine - Menoufia University', 'investigatorFullName': 'Amal Gouda Elsayed Safan', 'investigatorAffiliation': 'Menoufia University'}}}}