Ignite Creation Date:
2025-12-26 @ 10:18 PM
Ignite Modification Date:
2026-01-01 @ 2:50 AM
Study NCT ID:
NCT06944912
Status:
COMPLETED
Last Update Posted:
2025-04-27
First Post:
2025-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-24', 'studyFirstSubmitDate': '2025-04-18', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Obstetric Quality of Recovery-10 (ObsQoR-10) Score', 'timeFrame': 'Postoperative 24 hours', 'description': "The questionnaire's subscales are physical comfort (n=3 items), emotional state (n=2 items), pain (n=1 item), physical independence (n=2 items), and the ability to take care of the newborn (n=2 items). Each item is scored on a scale of 0-10, except for the first four items, which are graduated from 10 to 0. The total score is the sum of all item scores (i.e. a score ranging from 0 to 100, where 0 is the worst recovery score, and 100 indicates the best)."}], 'secondaryOutcomes': [{'measure': 'Opioid consumption', 'timeFrame': 'Postoperative 24. hours', 'description': 'Patient controlled analgesia based opioid requirement'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Recovery', 'Cesarean Section', 'Postoperative Pain', 'Transversalis Fascia Plane Block', 'Transversus Abdominis Plane Block', 'Intrathecal Opioid', 'ObsQoR-10 T'], 'conditions': ['Ceserean Section and Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '39039833', 'type': 'RESULT', 'citation': 'Pinarbasi A, Altiparmak B, Korkmaz Toker M, Pirincci F, Ugur B. Ultrasound-guided transversalis fascia plane block or transversus abdominis plane block for recovery after caesarean section: A randomised clinical trial. Eur J Anaesthesiol. 2024 Oct 1;41(10):769-778. doi: 10.1097/EJA.0000000000002041. Epub 2024 Jul 22.'}, {'pmid': '32412986', 'type': 'RESULT', 'citation': 'Aydin ME, Bedir Z, Yayik AM, Celik EC, Ates I, Ahiskalioglu EO, Ahiskalioglu A. Subarachnoid block and ultrasound-guided transversalis fascia plane block for caesarean section: A randomised, double-blind, placebo-controlled trial. Eur J Anaesthesiol. 2020 Sep;37(9):765-772. doi: 10.1097/EJA.0000000000001222.'}, {'pmid': '41408168', 'type': 'DERIVED', 'citation': 'Cadirci DY, Aydin ME, Ahiskalioglu EO, Celik EC, Yayik AM, Coruh S, Senocak GNC, Ciftci B, Ahiskalioglu A. Intrathecal morphine versus transversalis fascia and transversus abdominis plane blocks combination on obstetric quality of recovery after cesarean delivery: a randomized controlled trial. BMC Anesthesiol. 2025 Dec 17. doi: 10.1186/s12871-025-03559-0. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Cesarean delivery rates are rising globally, and effective postoperative analgesia is crucial for maternal recovery and newborn care. While intrathecal morphine offers strong analgesia, it may cause side effects such as nausea, pruritus, or respiratory depression. The transversus abdominis plane (TAP) block provides somatic pain relief but is often insufficient alone. The transversalis fascia plane block (TFPB) has been shown to enhance lower abdominal analgesia. This study aims to evaluate whether combining TAP and TFP blocks can provide analgesic efficacy comparable to intrathecal morphine in cesarean section patients who are unable to receive opioids or are at high risk of side effects.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-45 years old\n* American Society of Anesthesiologists physical score I or II\n* caesarean section with a Pfannenstiel incision\n\nExclusion Criteria:\n\n* additional surgical intervention, or received general anaesthesia,\n* hypersensitivity to the agents to be used\n* BMI greater than 35 kg m-2\n* coagulopathy,\n* local infection,\n* opioid addiction,\n* pregnancy-related hypertension\n* diabetes mellitus'}, 'identificationModule': {'nctId': 'NCT06944912', 'acronym': 'TAPTFPB', 'briefTitle': 'Transversus Abdominis and Transversalis Fascia Plane Block Combination for Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'Combined Transversalis Fascia and Transversus Abdominis Plane Blocks Versus Intrathecal Morphine: Effects on Postoperative Opioid Consumption and Obstetric Recovery After Cesarean Section', 'orgStudyIdInfo': {'id': 'AUTFTAPTFP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transversalis fascia+Transversus abominis plane block', 'interventionNames': ['Procedure: Transversalis fascia plane block and transversus abdominis plane block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intrathecal Morphine', 'interventionNames': ['Procedure: Intrathecal Morphine']}], 'interventions': [{'name': 'Transversalis fascia plane block and transversus abdominis plane block', 'type': 'PROCEDURE', 'description': '20 ml local anesthetics for Transversus Abdominis Plane block and 10 ml local anesthetics for Trasnversalis fascia plane block', 'armGroupLabels': ['Transversalis fascia+Transversus abominis plane block']}, {'name': 'Intrathecal Morphine', 'type': 'PROCEDURE', 'description': '100 mcg morphine with local anesthetics injected intrathecally', 'armGroupLabels': ['Intrathecal Morphine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25100', 'city': 'Erzurum', 'state': 'Yakutiye', 'country': 'Turkey (Türkiye)', 'facility': 'Atatürk University Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'overallOfficials': [{'name': 'Ali Ahiskalioglu, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Atatürk University, Faculty of Medicine, Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ataturk University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ali Ahiskalioglu', 'investigatorAffiliation': 'Ataturk University'}}}}