Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2026-01-01 @ 11:51 PM
Study NCT ID:
NCT05408403
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2022-06-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of TFPB and Anterior QLB on Postoperative Analgesia in Cesarean Section Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The anesthesia doctor who will perform the interfascial plane block (TFPB, anterior QLB) will be informed with a sealed envelope by an independent assistant outside the study, and the patient will not know which block is performed.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization of the study will be done by a doctor who will not participate in patient follow-up with closed envelopes using computer-generated randomization codes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-31', 'studyFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'The incidences of post-operative nausea and vomiting (PONV)', 'timeFrame': 'Postoperative Day 1', 'description': 'the presence of nausea and vomiting will be recorded for 24 hours after surgery'}, {'measure': 'The incidence of side effects related to local anesthetics, opioid use and regional anesthesia technic', 'timeFrame': 'Postoperative Day 1', 'description': 'respiratory depression, local anesthetic (LA) toxicity, hematoma and organ damage.'}], 'primaryOutcomes': [{'measure': 'Opioid consumption in the first 24 hours after surgery', 'timeFrame': 'Postoperative Day 1', 'description': 'Morphine consumption in the first 24 hours will be counted by IV patient controlled analgesia device (PCA). Patients will be able to request opioids via PCA device when the nrs score is above 4.'}], 'secondaryOutcomes': [{'measure': 'Post-operative acute pain', 'timeFrame': 'Postoperative Day 1', 'description': 'Pain status will be evaluated based on numeric rating scale (NRS) scores at rest and after movement. Pain status will be evaluated at 1, 3, 6, 9, 12, 18, 24. hours after surgery. Each NRS is scores 0-10. (0=no pain ; 10=worst pain imaginable)'}, {'measure': 'The time of first opioid requirement', 'timeFrame': 'Postoperative Day 1', 'description': 'The time of first opioid requirement will be recorded during the postoperative first 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia', 'Acute and chronical pain', 'Transversalis Fascia Plane Block', 'Quadratus Lumborum Blocks', 'Cesarean Section'], 'conditions': ['Analgesia', 'Acute Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study evaluates the postoperative analgesic effects of transversalis fascia plane block and anterior quadratus lumborum block in patients having cesarean section under general anesthesia. General anesthesia will be performed to all patients for the surgery.', 'detailedDescription': 'In this study, patients are divided into two groups. After the general anesthesia is performed and cesarean section surgery is over; TFPB block will be performed to patients in Group A ; while anterior QLB block will be performed to patients in Group B. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Group A - Patients in group A will have TFPB block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively. Group B - Patients in group B will have anterior QLB block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Pregnant women planned for elective cesarean operation', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being pregnant for at least 37 weeks\n* Planning an elective cesarean operation\n* Being between the ages of 18-45\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) 3-4 patients with comorbidities (Serious renal, cardiac, hepatic disease)\n* Being operated with spinal anesthesia\n* Obesity (\\> 100 kg, BMI\\> 35 kg / m2)\n* Contraindication of regional anesthesia (coagulopathy, abnormal international normalized ratio (INR), thrombocytopenia, infection at the injection site)\n* Hypersensitivity to local anesthetics or a history of allergy\n* Patients with a history of opioid use longer than four weeks\n* Patients with psychiatric disorders\n* Patients with anatomic deformity\n* Patients who do not want to participate'}, 'identificationModule': {'nctId': 'NCT05408403', 'briefTitle': 'Comparison of the Effects of TFPB and Anterior QLB on Postoperative Analgesia in Cesarean Section Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Comparison of the Effects of Transversalis Fascia Plane Block and Anterior QLB ( TFPB and Anterior QLB ) on Postoperative Analgesia in Cesarean Section Surgery', 'orgStudyIdInfo': {'id': 'TFPB-QLB3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transversalis Fascia Plane Block', 'description': 'Transversalis Fascia Plane Block (TFPB) will be performed the patients in Group A after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively', 'interventionNames': ['Other: Regional anesthesia TFPB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum Block', 'description': 'Anterior Quadratus Lumborum Block ( Anterior QLB) will be performed the patients in Group B after the cesarean section surgery. Patient controlled analgesia device (PCA) is used for all the patients in the first 24 hours postoperatively', 'interventionNames': ['Other: Regional anesthesia QLB']}], 'interventions': [{'name': 'Regional anesthesia TFPB', 'type': 'OTHER', 'otherNames': ['Transversalis Fascia Plane Block'], 'description': 'Transversalis Fascia Plane Block will be performed with 25 mL of 0.25% bupivacaine,after the end of cesarean surgery before extubation.', 'armGroupLabels': ['Transversalis Fascia Plane Block']}, {'name': 'Regional anesthesia QLB', 'type': 'OTHER', 'otherNames': ['Anterior Quadratus Lumborum Block'], 'description': 'Anterior Quadratus Lumborum Block will be performed with 25 mL of 0.25% bupivacaine, after the end of cesarean surgery before extubation.', 'armGroupLabels': ['Quadratus Lumborum Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200', 'city': 'Samsun', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University Faculty of Medicine', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'Sezgin Bilgin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ondokuz Mayıs University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'SEZGİN BİLGİN', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}