Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-30 @ 2:43 PM
Study NCT ID:
NCT05758233
Status:
COMPLETED
Last Update Posted:
2023-07-17
First Post:
2023-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003075', 'term': 'Coitus'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D012725', 'term': 'Sexual Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'prospective randomize study'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective randomize study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-07', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-13', 'studyFirstSubmitDate': '2023-02-20', 'studyFirstSubmitQcDate': '2023-02-24', 'lastUpdatePostDateStruct': {'date': '2023-07-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time of first analgesic need', 'timeFrame': '24 hours postoperatively', 'description': 'Our primary goal was to meet the initial analgesic requirement times.'}], 'secondaryOutcomes': [{'measure': 'visuel analog scale', 'timeFrame': '24 hours postoperatively', 'description': 'Our secondary aim was to compare postoperative pain scores. The first 24 hours postoperatively were evaluated.Visual analog scale(VAS) was used to assess postoperative pain.6th, 12th, 24th hour VAS values were recorded For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anesthesia recovery period', 'cesarean section', 'obstetric anesthesia', 'spinal anaesthesia', 'postoperative analgesia'], 'conditions': ['Anesthesia; Sexual', 'Analgesia']}, 'referencesModule': {'references': [{'pmid': '35455750', 'type': 'BACKGROUND', 'citation': 'Ryu C, Choi GJ, Jung YH, Baek CW, Cho CK, Kang H. Postoperative Analgesic Effectiveness of Peripheral Nerve Blocks in Cesarean Delivery: A Systematic Review and Network Meta-Analysis. J Pers Med. 2022 Apr 14;12(4):634. doi: 10.3390/jpm12040634.'}, {'pmid': '31653797', 'type': 'RESULT', 'citation': 'Mitchell KD, Smith CT, Mechling C, Wessel CB, Orebaugh S, Lim G. A review of peripheral nerve blocks for cesarean delivery analgesia. Reg Anesth Pain Med. 2019 Oct 25:rapm-2019-100752. doi: 10.1136/rapm-2019-100752. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia.\n\nThe main question\\[s\\] it aims to answer are:\n\n\\[Is transversalis fascia plane block more effective in postoperative analgesia? \\]\n\n\\[Is there a difference between the duration of postoperative first analgesia requirement? \\] Since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.', 'detailedDescription': 'This prospective, randomized trial was conducted at Başakşehir Çam and Sakura City Hospital by the Declaration of Helsinki. After ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to Consolidated Standards of Reporting Trials (CONSORT) guidelines.A total of 150 patients were divided into two groups: transversal fascia plane block (TFPB group) and Transversus abdominis plane block (TAPB group).VAS values, time to first analgesic requirement, analgesic requirements, nausea \\& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (T2), 12th hour (T3), 24th hour .'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': '20-50 age', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20-50 years old pregnant woman\n* ASAII-III\n* Patients accepting spinal anesthesia\n\nExclusion Criteria:\n\n* Morbid obesity(BMI \\>40)\n* Patients who are switched to general anesthesia in an unexpected perioperative situation\n* Patients with placental anomaly\n* Patients with bupivacaine allergy\n* Fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia'}, 'identificationModule': {'nctId': 'NCT05758233', 'briefTitle': 'The Effect of Peripheral Nerve Blocks on Postoperative Analgesia in Elective Cesarean Section', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}, 'officialTitle': 'Comparison of the Effectiveness of Ultrasound-guided Transversalis Fascia Plane Block and Transversus Abdominis Plane Block on Postoperative Pain in Caesarean Section : a Prospective Randomized Trial', 'orgStudyIdInfo': {'id': '2022-74'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Grup 1: Transversalis Fascia Plane Block (TFPB)', 'description': 'Transversalis Fascia Plane Block (TFPB)', 'interventionNames': ['Procedure: Patients undergoing transversalis fascia plane block', 'Procedure: Patients undergoing transversus abdominis plane block']}, {'type': 'EXPERIMENTAL', 'label': 'Grup 2: Transversus Abdominis Plane Block (TAPB)', 'description': 'Transversus Abdominis Plane Block (TAPB)', 'interventionNames': ['Procedure: Patients undergoing transversalis fascia plane block', 'Procedure: Patients undergoing transversus abdominis plane block']}], 'interventions': [{'name': 'Patients undergoing transversalis fascia plane block', 'type': 'PROCEDURE', 'description': 'The investigators applied a transversalis fascia plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.', 'armGroupLabels': ['Grup 1: Transversalis Fascia Plane Block (TFPB)', 'Grup 2: Transversus Abdominis Plane Block (TAPB)']}, {'name': 'Patients undergoing transversus abdominis plane block', 'type': 'PROCEDURE', 'description': 'The investigators applied a transversus abdominis plane block to the group of patients who had a cesarean section under spinal anesthesia to prevent postoperative pain.', 'armGroupLabels': ['Grup 1: Transversalis Fascia Plane Block (TFPB)', 'Grup 2: Transversus Abdominis Plane Block (TAPB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3268', 'city': 'Istanbul', 'state': 'Basaksehir', 'country': 'Turkey (Türkiye)', 'facility': 'Başakşehir Çam and Sakura City Hospital', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Duygu Akyol, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Başakşehir Çam & Sakura City Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Duygu Akyol', 'investigatorAffiliation': 'Bakirkoy Dr. Sadi Konuk Research and Training Hospital'}}}}