Ignite Creation Date:
2025-12-26 @ 5:23 PM
Ignite Modification Date:
2025-12-28 @ 7:51 PM
Study NCT ID:
NCT04364906
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2020-04-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Effects of QLB 2 and QLB 3 on Post-operative 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, '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 (QLB 2, 3) 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': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-15', 'studyFirstSubmitDate': '2020-04-23', 'studyFirstSubmitQcDate': '2020-04-23', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption in the first 24 hours after surgery', 'timeFrame': '1 day', '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': '1 day', 'description': 'Pain status will be evaluated based on NRS scores. 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=pain as bad as can be)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Regional Anesthesia', 'Acute and chronical pain', 'Quadratus Lumborum Blocks', 'Cesarean Section', 'Spinal Anesthesia'], 'conditions': ['Analgesia', 'Acute Pain', 'Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This study evaluates the post-operative analgesic effects of quadratus lomborum block 2 and 3 (QLB 2, 3) in patients having cesarean section with spinal anesthesia. Spinal anesthesia will be performed to all patients for the surgery.', 'detailedDescription': 'In this study, patients are divided into two groups. After the spinal anesthesia is performed and cesarean section surgery is over; QLB 2 block will be performed to patients in Group A ; while QLB 3 block will be performed to patients in Group B.\n\nIn addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.\n\nGroup A - Patients in group A will have QLB 2 block after the surgery. In addition, patient controlled analgesia (PCA) will be used in the first 24 hours postoperatively.\n\nGroup B - Patients in group B will have QLB 3 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* ASA 3-4 patients with comorbitidies (Serious renal, cardiac, hepatic disease)\n* Being operated with general anesthesia\n* Obesity (\\> 100 kg, BMI\\> 35 kg / m2)\n* Contraindication of regional anesthesia (quagulopathy, abnormal 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': 'NCT04364906', 'briefTitle': 'Comparison of the Effects of QLB 2 and QLB 3 on Post-operative Analgesia in Cesarean Section Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'Comparison of the Effects of Quadratus Lumborum Block 2 and 3 (QLB 2 and QLB 3) on Post-operative Analgesia in Cesarean Section Surgery', 'orgStudyIdInfo': {'id': 'QL20011990'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum Block 2', 'description': 'Quadratus Lumborum Block 2 (QLB 2) 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']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum Block 3', 'description': 'Quadratus Lumborum Block 3 (QLB 3) 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']}], 'interventions': [{'name': 'Regional anesthesia', 'type': 'OTHER', 'otherNames': ['Quadratus Lumborum Block 2', 'Quadratus Lumborum Block 3'], 'description': 'The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery', 'armGroupLabels': ['Quadratus Lumborum Block 2', 'Quadratus Lumborum Block 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55200', 'city': 'Samsun', 'state': 'Other', 'country': 'Turkey (Türkiye)', 'facility': 'Ondokuz Mayıs University Faculty of Medicine', 'geoPoint': {'lat': 41.27976, 'lon': 36.3361}}], 'overallOfficials': [{'name': 'ERSİN KÖKSAL, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ondokuz Mayıs University Faculty of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Caner Genç', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}