Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-31 @ 8:51 AM
Study NCT ID:
NCT02489851
Status:
COMPLETED
Last Update Posted:
2016-05-24
First Post:
2015-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block vs Tranversus Abdominis Plane Block 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': 76}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-22', 'studyFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2016-05-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total morphine used in the first 48 hours after surgery', 'timeFrame': '48 hours', 'description': 'Total cumulative morphine dose in mg used in the first 48 hours after surgery'}], 'secondaryOutcomes': [{'measure': 'Severity of postoperative pain via visual analogue pain scale (VAS)', 'timeFrame': '48 hours', 'description': 'VAS range from 0 for no pain to 10 for worst pain imaginable'}, {'measure': 'Nausea or vomiting', 'timeFrame': '48 hours', 'description': '0 = No Nausea\n\n1. = Mild Nausea.\n2. = Moderate\n3. = Severe Nausea or Vomiting'}, {'measure': 'Sedation score', 'timeFrame': '48 hours', 'description': '1. = drowsy but responds to normal verbal communication.\n2. = asleep, but awakes with verbal communication.\n3. = asleep, awakens with mild physical stimulation.\n4. = asleep, unresponsive to mild physical stimulation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '27755488', 'type': 'DERIVED', 'citation': 'Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.'}]}, 'descriptionModule': {'briefSummary': 'The Quadratus Lumborum block (QLB) was first described by Blanco in 2007. The main advantage of QLB compared to the Transversus Abdominis Plane block (TAP) is the extension of local anesthetic agent beyond the TAP plane to the thoracic paravertebral space. The wider spread of the local anesthetic agents may produce extensive analgesia and prolonged action of the injected local anesthetic solution.\n\nPrevious studies showed that both TAP block and QLB may reduce morphine requirements in the postoperative period in patients who had cesarean section under spinal anaesthesia. However there are no published reports comparing the 2 techniques.\n\nThe aim of this randomised controlled, double blinded study is to compare the analgesic efficacy of QLB compared to TAP block in patients who had cesarean section under spinal anesthesia.', 'detailedDescription': 'After ethical committee approval, informed written consent will be obtained from all patients. A Sample size of 72 patients (36 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.\n\nConsenting patients scheduled to have elective cesarean section under spinal anesthesia will be randomised to receive bilateral QLB or TAP at the end of surgery.The dose of local anaesthetic in both groups will be 0.2 ml/kg 0.125% Bupivacaine. Allocation to either group will be done using closed envelope technique.\n\nAll the blocks will be performed in operation theatre after the end of cesarean section with intravenous access, ECG, BP, oxygen saturation by pulse oximetry monitoring and full resuscitation equipment and medication ready.\n\nAll patients will be in the supine position . Under ultrasound guidance a 22 Gauge, two inch Pajunk Sonoplex needle will be used for both techniques. The calculated dose of local anaeshetic will be injected bilateraly with intermittent aspiration. The spread of injectate will be seed on ultrasound.\n\nAll patients will receive the routine postoperative analgesia, comprising patient-controlled IV morphine analgesia and regular diclofenac and paracetamol.\n\nAll patients will be assessed postoperatively by a blinded investigator: in the postanesthesia care unit and at 2, 4, 6, 12, 24, 36, and 48 h postoperatively.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nElective caesarean sections ASA 1 to 3 Written informed consent.\n\nExclusion Criteria:\n\nPatient refusal Local infection at the site of injection Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy Inability to comprehend or participate in pain scoring system Inability to use intravenous patient controlled analgesia'}, 'identificationModule': {'nctId': 'NCT02489851', 'briefTitle': 'Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Cesarean Section', 'organization': {'class': 'OTHER', 'fullName': 'Corniche Hospital'}, 'officialTitle': 'Quadratus Lumborum Block vs Tranversus Abdominis Plane Block for Post Cesarean Section Analgesia. A Randomised Controlled Study', 'orgStudyIdInfo': {'id': 'Ch23031404'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus Lumborum block group', 'description': 'Quadratus Lumborum block group (QL)\n\npatients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%', 'interventionNames': ['Procedure: Quadratus Lumborum block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Transversus abdominis plane block group', 'description': 'Transversus abdominis plane block (TAP)\n\npatients will receive a bilateral TAP block using Bupivicaine 0.125%', 'interventionNames': ['Procedure: Tranversus Abdominis plane block']}], 'interventions': [{'name': 'Quadratus Lumborum block', 'type': 'PROCEDURE', 'otherNames': ['QLB'], 'description': '0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle', 'armGroupLabels': ['Quadratus Lumborum block group']}, {'name': 'Tranversus Abdominis plane block', 'type': 'PROCEDURE', 'otherNames': ['TAP'], 'description': '0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.', 'armGroupLabels': ['Transversus abdominis plane block group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3788', 'city': 'Abu Dhabi', 'country': 'United Arab Emirates', 'facility': 'Corniche Hospital', 'geoPoint': {'lat': 24.45118, 'lon': 54.39696}}], 'overallOfficials': [{'name': 'Rafa Blanco, FRCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corniche Hospital'}, {'name': 'Tarek Ansari, FFARCSI', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corniche Hospital'}, {'name': 'Nanda Shetty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Corniche Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Corniche Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}