Ignite Creation Date:
2025-12-24 @ 3:17 PM
Ignite Modification Date:
2025-12-27 @ 3:15 AM
Study NCT ID:
NCT05750992
Status:
RECRUITING
Last Update Posted:
2024-07-31
First Post:
2023-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D008614', 'term': 'Meperidine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-30', 'studyFirstSubmitDate': '2023-02-19', 'studyFirstSubmitQcDate': '2023-02-28', 'lastUpdatePostDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to perform block.', 'timeFrame': '1 hour postoperatively', 'description': 'The time taken to perform the block will be recorded by an independent observer.'}], 'secondaryOutcomes': [{'measure': 'Heart rate', 'timeFrame': '24 hours postoperatively', 'description': 'Patients hemodynamics (heart rate will be recorded)'}, {'measure': 'Mean arterial blood pressure', 'timeFrame': '24 hours postoperatively', 'description': 'Patients hemodynamics (mean arterial blood pressure will be recorded)'}, {'measure': 'Pain score', 'timeFrame': '24 hours postoperatively', 'description': "The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be')."}, {'measure': 'Time to first analgesic request', 'timeFrame': '24 hours postoperatively', 'description': 'The time to first analgesic request will be recorded'}, {'measure': 'Amount of post operative analgesic consumption', 'timeFrame': '24 hours postoperatively', 'description': 'The amount of post operative analgesic consumption will be recorded'}, {'measure': 'Time spent in operating room', 'timeFrame': '24 hours postoperatively', 'description': 'The time spent in operating room will be recorded'}, {'measure': 'Incidence of Adverse reactions', 'timeFrame': '24 hours postoperatively', 'description': 'Adverse events will be recorded such as nausea, vomiting, hypotension (Mean arterial blood pressure \\< 20% of baseline readings and will be managed by ephedrine 5 mg IV and/or normal saline IV) and bradycardia (heart rate \\< 60 beats/min and will be managed by atropine 0.6 mg IV).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section', 'Ultrasound Guided Transversus Abdominis Plane Block', 'Surgical Transversus Abdominis Plane Block', 'Bupivacaine', 'Acute Pain']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to compare Surgical Transversus abdominis plane block and Ultrasound guided transversus abdominis plane block (TAPB) as a postoperative analgesic regimen in female patients undergoing elective cesarean delivery.', 'detailedDescription': "Caesarean delivery rates have been increasing worldwide nowadays. At rate of \\[52%\\], Egypt stands out among countries with the world's highest cesarean delivery percentages . Within the Arab region, rate of cesarean section far higher in Egypt than other Arab countries.\n\nA much simpler and theoretically superior means of establishing a TAP block. When using a transcutaneous (conventional) approach there is always the risk of peritoneal puncture with its attendant complications. Moreover, there are technical difficulties, especially in obese women and the procedure requires specialist equipment, a skilled operator and training in ultrasonography. Our approach obviates these risks and difficulties because the procedure is carried out under direct vision, and it is much easier to perform by the surgeon during caesarean section."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '21 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full term pregnant women\n* Older than 21 years of age\n* Had elective cesarean section with Pfannenstiel incision.\n\nExclusion Criteria:\n\n* Patients with cesarean section using different surgical incision\n* History of addiction \\[including opioids and benzodiazepines\\]\n* Allergy to the anesthetic analgesia\n* Psychological disorders\n* Coagulopathies\n* Infection at the block injection site.'}, 'identificationModule': {'nctId': 'NCT05750992', 'briefTitle': 'Ultrasound Guided TAPB vs Surgical TAPB With Bupivacaine in Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Ultrasound Guided Transversus Abdominis Plane Block (TAPB) vs Surgical TAPB With Bupivacaine for Acute Pain Control in Cesarean Section: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'DFM-IRB 00012367- 23-02-006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'surgical TAP block', 'description': 'twenty-five pregnant women will receive surgical TAP block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.', 'interventionNames': ['Procedure: surgical TAP block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'US guided TAP block', 'description': '25 pregnant women will receive US guided T.A.P block performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.', 'interventionNames': ['Procedure: US guided TAP block']}], 'interventions': [{'name': 'surgical TAP block', 'type': 'PROCEDURE', 'otherNames': ['bupivacaine, normal saline, fentanyl, pethidine'], 'description': 'performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally by the surgeon.', 'armGroupLabels': ['surgical TAP block']}, {'name': 'US guided TAP block', 'type': 'PROCEDURE', 'otherNames': ['bupivacaine, normal saline, fentanyl , pethidine'], 'description': 'performed by 40 ml of 0.25% bupivacaine (10 ml 0.5% bupivacaine bilaterally diluted with 10cc normal saline and 100 μg of fentanyl), the total volume was divided equally and administered bilaterally.', 'armGroupLabels': ['US guided TAP block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11865', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Neveen A. Kohaf, Ph.D', 'role': 'CONTACT', 'phone': '01069482380'}], 'facility': 'Kohaf', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Neveen A. Kohaf, Ph.D', 'role': 'CONTACT', 'email': 'nevenabdo@azhar.edu.eg', 'phone': '+201069482380'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'for one year after completion of the study', 'ipdSharing': 'YES', 'description': 'The data will be available upon reasonable request from the principle investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Clinical Pharmacy', 'investigatorFullName': 'Neveen Abd El Maksoad Kohaf', 'investigatorAffiliation': 'Al-Azhar University'}}}}