Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2026-02-24 @ 5:06 AM
Study NCT ID:
NCT03333902
Status:
COMPLETED
Last Update Posted:
2019-01-24
First Post:
2017-11-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Comparison Of Nerve Blocks In 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016058', 'term': 'Analgesia, Patient-Controlled'}], 'ancestors': [{'id': 'D000698', 'term': 'Analgesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-23', 'studyFirstSubmitDate': '2017-11-02', 'studyFirstSubmitQcDate': '2017-11-05', 'lastUpdatePostDateStruct': {'date': '2019-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the change trend of Visual Analogue Scale (VAS) at rest and movement', 'timeFrame': '0-48 hours postoperatively', 'description': 'The purpose is to view the change of the level of pain assessed by subjects at adjacent time points. We would set 0, 4, 6, 12, 24, 48 hours postoperatively as observational time points.'}], 'secondaryOutcomes': [{'measure': 'total morphine consumption', 'timeFrame': '0-48 hours postoperatively', 'description': 'total morphine consumption'}, {'measure': 'complications', 'timeFrame': '0-48 hours postoperatively', 'description': 'nausea, vomiting, retention of urine, lower limb weakness, etc.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['quadratus lumborum block', 'anesthesia', 'pain, postoperative'], 'conditions': ['Anesthesia, Obstetrical']}, 'referencesModule': {'references': [{'pmid': '26225500', 'type': 'BACKGROUND', 'citation': 'Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effect of different kinds of popular peripheral nerve blocks for postoperative analgesia after cesarean delivery is completed, compared with traditional epidual analgesia.', 'detailedDescription': 'Visual Analogue Scale (VAS) and morphine consumption was adopted to evaluate the pain relief.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '24 Years', 'genderBased': True, 'genderDescription': 'Subjects undergo cesarean delivery', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) physical status I or II\n* weight from 50 to 70 kilogrammes\n* a normal singleton pregnancy\n* ≥37 weeks gestation\n\nExclusion Criteria:\n\n* congenital coagulopathy\n* anatomic abnormalities\n* localized skin infection\n* allergy to any of the drugs used'}, 'identificationModule': {'nctId': 'NCT03333902', 'briefTitle': 'The Comparison Of Nerve Blocks In Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'First Affiliated Hospital, Sun Yat-Sen University'}, 'officialTitle': 'The Comparison Of Different Nerve Blocks For Postoperative Analgesia In Cesarean Delivery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '[2016]123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLB type 2', 'description': 'Ultrasound-guided, Inject at the point posterior to quadratus lumborum muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.\n\nSubjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.', 'interventionNames': ['Procedure: QLB', 'Procedure: Intravenous patient controlled analgesia (PCA)']}, {'type': 'EXPERIMENTAL', 'label': 'QLB type 3', 'description': 'Ultrasound-guided, Inject at the point between the quadratus lumborum and the psoas major muscle, 0.2% ropivacaine 30mL in each side for a total of 60mL.\n\nSubjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.', 'interventionNames': ['Procedure: QLB', 'Procedure: Intravenous patient controlled analgesia (PCA)']}, {'type': 'EXPERIMENTAL', 'label': 'QLB type 2+3', 'description': 'Ultrasound-guided, conduct both QLB type 2 and 3, 0.2% ropivacaine 15mL in each point of injection, for a total of 60mL.\n\nSubjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.', 'interventionNames': ['Procedure: QLB', 'Procedure: Intravenous patient controlled analgesia (PCA)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'epidural anesthesia group (EA)', 'description': 'Epidural catheter placement was conducted when finishing spinal anesthesia. After surgery, 30 mL saline (placebo) was Injected at the point posterior to the quadratus lumborum in each side for a total of 60mL. We used a single bolus of 0.15% ropivacaine + 2 mg morphine (diluted in 6 ml saline) via epidural cathether.\n\nSubjects also receive an intravenous patient controlled analgesia (PCA) pump of 0.5 mg/mL morphine for 48 hours.', 'interventionNames': ['Procedure: QLB', 'Procedure: Intravenous patient controlled analgesia (PCA)']}], 'interventions': [{'name': 'QLB', 'type': 'PROCEDURE', 'description': 'QLB, quadratus lumborum block.', 'armGroupLabels': ['QLB type 2', 'QLB type 2+3', 'QLB type 3', 'epidural anesthesia group (EA)']}, {'name': 'Intravenous patient controlled analgesia (PCA)', 'type': 'PROCEDURE', 'description': 'Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.', 'armGroupLabels': ['QLB type 2', 'QLB type 2+3', 'QLB type 3', 'epidural anesthesia group (EA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'The First Affiliated Hospital of Sun Yat-Sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Feng Xia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Feng Xia', 'investigatorAffiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}}}}