Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2026-01-07 @ 4:07 AM
Study NCT ID:
NCT03811067
Status:
COMPLETED
Last Update Posted:
2019-07-23
First Post:
2019-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2019-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-07-22', 'studyFirstSubmitDate': '2019-01-18', 'studyFirstSubmitQcDate': '2019-01-18', 'lastUpdatePostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': 'Postoperative 24th hour.', 'description': 'Morphine consumption (mg) of patients with patient controlled device'}, {'measure': 'NRS score', 'timeFrame': 'Postoperative 24th hour', 'description': 'Numerating rating scale of patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative pain', 'Transversus abdominis plane block', 'Rectus sheath block', 'Cesarean delivery'], 'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Importance of effective postoperative pain management is well known. The undesired effects of pain can be prevented with multimodal analgesia for the patient. Overall, for cesarean delivery, interaction between the mother and her newborn baby can be provided earlier. Many regional anesthesia techniques can be prefferred after cesarean delivery. Aim of the study is to compare the postoperative analgesia effects of transversus abdominis plane block and rectus sheath block after elective cesarean delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nASA I-II patients Patients undergo elective cesarean delivery Gestation period between 37-40 weeks\n\nExclusion Criteria:\n\nobesity (body mass index \\>35 kg/m2) infection of the skin at the site of needle puncture area patients with known allergies to any of the study drugs coagulopathy'}, 'identificationModule': {'nctId': 'NCT03811067', 'briefTitle': 'Transversus Abdominis Plane Block Versus Rectus Sheath Block After Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli University'}, 'officialTitle': 'Transversus Abdominis Plane Block Versus Rectus Sheath Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'KAEK 2017/348'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAP group', 'description': 'Transversus abdominis plane block administered group', 'interventionNames': ['Procedure: Transversus abdominis plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'RS group', 'description': 'Rectus sheath block administered group', 'interventionNames': ['Procedure: Rectus sheath block']}], 'interventions': [{'name': 'Transversus abdominis plane block', 'type': 'PROCEDURE', 'description': 'Transversus abdominis plane block will be performed bilaterally after the surgery.', 'armGroupLabels': ['TAP group']}, {'name': 'Rectus sheath block', 'type': 'PROCEDURE', 'description': 'Rectus sheath block will be performed bilaterally after the surgery.', 'armGroupLabels': ['RS group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41350', 'city': 'Kocaeli', 'country': 'Turkey (Türkiye)', 'facility': 'Kocaeli University', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}], 'overallOfficials': [{'name': 'Hadi Ufuk MD Yörükoğlu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kocaeli University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Hadi Ufuk Yörükoğlu', 'investigatorAffiliation': 'Kocaeli University'}}}}