Ignite Creation Date:
2025-12-24 @ 9:33 PM
Ignite Modification Date:
2025-12-25 @ 7:17 PM
Study NCT ID:
NCT06292832
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-05
First Post:
2024-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-27', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-27', 'lastUpdatePostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative time to rescue analgesia requirement', 'timeFrame': '24 hours', 'description': 'Time'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cesarean Section Complications']}, 'descriptionModule': {'briefSummary': 'The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.', 'detailedDescription': 'The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II women scheduled for elective CS under intrathecal anesthesia.\n\nExclusion Criteria:\n\n* had local infection, bleeding disorder or known allergy to any of the study medications'}, 'identificationModule': {'nctId': 'NCT06292832', 'briefTitle': 'Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control', 'organization': {'class': 'OTHER', 'fullName': 'Al-Azhar University'}, 'officialTitle': 'Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Pain Control After Cesarean Section in Obese and Morbidly Obese Women', 'orgStudyIdInfo': {'id': 'MSR/AZAST/AIP029/22/222/8/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Obese Spinae Plane Block', 'description': 'Spinae Plane Block for pain control', 'interventionNames': ['Procedure: Ultrasound-guided pain block', 'Device: Ultrasound Machine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Obese Transversus Abdominis Plane Block', 'description': 'Transversus Abdominis Plane Block for pain control.', 'interventionNames': ['Procedure: Ultrasound-guided pain block', 'Device: Ultrasound Machine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morbidly Obese Spinae Plane Block', 'description': 'Spinae Plane Block for pain control', 'interventionNames': ['Procedure: Ultrasound-guided pain block', 'Device: Ultrasound Machine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morbidly Obese Transversus Abdominis Plane Block', 'description': 'Transversus Abdominis Plane Block for pain control.', 'interventionNames': ['Procedure: Ultrasound-guided pain block', 'Device: Ultrasound Machine']}], 'interventions': [{'name': 'Ultrasound-guided pain block', 'type': 'PROCEDURE', 'description': 'Ultrasound-guided pain block after cesarean section', 'armGroupLabels': ['Morbidly Obese Spinae Plane Block', 'Morbidly Obese Transversus Abdominis Plane Block', 'Obese Spinae Plane Block', 'Obese Transversus Abdominis Plane Block']}, {'name': 'Ultrasound Machine', 'type': 'DEVICE', 'description': 'Ultrasound machine used to guide the nerve block.', 'armGroupLabels': ['Morbidly Obese Spinae Plane Block', 'Morbidly Obese Transversus Abdominis Plane Block', 'Obese Spinae Plane Block', 'Obese Transversus Abdominis Plane Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'Warda Ali', 'role': 'CONTACT', 'email': 'warda2001@hotmail.com', 'phone': '010300020456'}], 'facility': 'Al-Azhar University', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Warda Ali', 'role': 'CONTACT', 'email': 'warda2001@hotmail.com', 'phone': '00109939124'}], 'overallOfficials': [{'name': 'Warda Ali', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University, Assiut, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Al-Azhar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Warda Demerdash Khalifa Ali', 'investigatorAffiliation': 'Al-Azhar University'}}}}