Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT03502369
Status:
UNKNOWN
Last Update Posted:
2018-04-19
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty
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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Adult 90 orthopaedic patient ASA physical status \\|-\\|\\|\\| will be randomly allocated in two groups each one 45 patients, one group will receive the anterior quadratus lumborum block and the other group will not receive the block.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2019-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-04-17', 'studyFirstSubmitDate': '2018-04-11', 'studyFirstSubmitQcDate': '2018-04-11', 'lastUpdatePostDateStruct': {'date': '2018-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient satisfaction.', 'timeFrame': 'every hour in the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.', 'description': 'Patient satisfaction with pain control will be assessed on a four point scale 1.Excellent 2.Good 3.fair 4.poor'}], 'primaryOutcomes': [{'measure': 'Pain intensity assessment', 'timeFrame': 'every hour for the first 4 post operative hours and then every 4 hours for the rest of the 24 post operative hours.', 'description': 'Patients will be trained to use visual analogue scale which consists of 10cm line, 0 cm equivalent to no pain and 10 cm denoting the worst imaginable pain.'}], 'secondaryOutcomes': [{'measure': 'Total amount of post operative morphine (mg).', 'timeFrame': 'any time in the first 24 post operative hours.', 'description': 'Total amount of post operative morphine (mg) used as rescue analgesia and the first time of its request.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'referencesModule': {'references': [{'pmid': '28154824', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.'}, {'pmid': '26426575', 'type': 'RESULT', 'citation': 'Sauter AR, Ullensvang K, Niemi G, Lorentzen HT, Bendtsen TF, Borglum J, Pripp AH, Romundstad L. The Shamrock lumbar plexus block: A dose-finding study. Eur J Anaesthesiol. 2015 Nov;32(11):764-70. doi: 10.1097/EJA.0000000000000265.'}]}, 'descriptionModule': {'briefSummary': 'The study evaluates the effectiveness of anterior quadratus lumborum block for post operative analgesia after hip arthroplasty. Half of the participants will receive ultrasound guided anterior quadratus lumborum block using 30ml bupivacaine 0.375%, while the other half will not receive the block ( control group).', 'detailedDescription': 'Sensory innervation of the hip region involves branches of the lumbar plexus and sacral plexus. Effective post operative analgesia can be approached by blocking the lumbar plexus at the level of the quadratus lumborum muscle. Quadratus lumborum block has several approach methods (anterior, lateral, posterior, and intramuscular). Anterior quadratus lumborum block also known as transmuscular QL block or QL3, the local anaesthetic (30ml of bupivacaine 0.375%) is injected between the psoas major muscle (PM) and the quadratus lumborum muscle (QL). Therefore, the anterior quadratus lumborum block may generate analgesia from T10 to L4 covering the sensory innervation of the hip region.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of anesthesiologists physical status \\|-\\|\\|\\| , scheduled to undergo unilateral hip replacement via lateral approach.\n\nExclusion Criteria:\n\n* patient refusal.\n* History of neurological/neuromuscular, psychiatric, dementia preventing proper comprehension.\n* coagulation disorders.\n* History of allergy to the study medication.\n* Infection overlying the injection site.'}, 'identificationModule': {'nctId': 'NCT03502369', 'briefTitle': 'Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Randomized, Controlled, Double Blind Trial of Ultrasound Guided Quadratus Lumborum Block for Post Operative Analgesia After Hip Arthroplasty', 'orgStudyIdInfo': {'id': '050108004'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QL group', 'description': 'Anterior Quadratus lumborum block will be done for all patients of these group. Local anaesthetic (30ml of bupivacaine) will be injected in fascial plane between the quadratus lumborum muscle and Psoas major muscle by using the ultrasound.', 'interventionNames': ['Procedure: Anterior Quadratus lamborum block']}, {'type': 'NO_INTERVENTION', 'label': 'C group', 'description': 'Patients of these group will be the control group. The will receive acetaminophen 1g every 8h, ketorolac 30mg ever 12h and as required morphine 2mg for post operative analgesia after hip arthroplasty.'}], 'interventions': [{'name': 'Anterior Quadratus lamborum block', 'type': 'PROCEDURE', 'otherNames': ['Transmuscular QL block', 'QL3'], 'description': 'Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.', 'armGroupLabels': ['QL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21519', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'moutaz Ghandour, professor', 'role': 'CONTACT', 'email': 'moutaz.ghandour@alexmed.edu.eg', 'phone': '01003363712'}, {'name': 'Abdullah Gaber, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Alexandria faculty of medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Data will be available within 6 months of study completion.', 'ipdSharing': 'YES', 'description': 'De identified individual participant data for all primary and secondary outcome measures will be made available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Registeral', 'investigatorFullName': 'Abdullah Gaber', 'investigatorAffiliation': 'Alexandria University'}}}}