Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-02-19 @ 4:39 PM
Study NCT ID:
NCT03733769
Status:
COMPLETED
Last Update Posted:
2019-01-17
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Novel Approach for Transmuscular Quadratus Lumborum Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-16', 'studyFirstSubmitDate': '2018-11-06', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2019-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'peri-operative analgesia in hip Surgery', 'timeFrame': 'one month', 'description': 'post-operative VAS score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Transmuscular Quadratus Lumborum Block Hip Surgery']}, 'referencesModule': {'references': [{'pmid': '30386022', 'type': 'BACKGROUND', 'citation': 'Adhikary SD, Short AJ, El-Boghdadly K, Abdelmalak MJ, Chin KJ. Transmuscular quadratus lumborum versus lumbar plexus block for total hip arthroplasty: A retrospective propensity score matched cohort study. J Anaesthesiol Clin Pharmacol. 2018 Jul-Sep;34(3):372-378. doi: 10.4103/joacp.JOACP_335_17.'}, {'pmid': '27730633', 'type': 'BACKGROUND', 'citation': 'Adhikary SD, El-Boghdadly K, Nasralah Z, Sarwani N, Nixon AM, Chin KJ. A radiologic and anatomic assessment of injectate spread following transmuscular quadratus lumborum block in cadavers. Anaesthesia. 2017 Jan;72(1):73-79. doi: 10.1111/anae.13647. Epub 2016 Oct 12.'}, {'pmid': '27543534', 'type': 'BACKGROUND', 'citation': 'Carline L, McLeod GA, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anaesth. 2016 Sep;117(3):387-94. doi: 10.1093/bja/aew224.'}]}, 'descriptionModule': {'briefSummary': 'a novel approach for TQL (anterior Q.L) block aiming mainly for terminal branches of lumbar plexus. The technique is described as Para-Spinous Saggital Shift Q.L block, done at L4 transverse process level in saggital orientation.', 'detailedDescription': 'With this approach, we think it has advantages of easy identification, better caudal LA spread till under fascia iliaca, with the psoas major muscle provides a better protective barrier against accidental needle entry into the peritoneal cavity, the endpoint is injection within a fascial plane, rather than a specific motor response contact where the lumbar plexus stimulation is not sought, so there is minimal risk of nerve injury, inadvertent dural cuff puncture and intrathecal spread of local anesthetic. And finally optimal insertion of catheter in long axis of Q.L and psoas major if continuous analgesia is planned.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Orthopaedic patients, American Society of Anesthesiologists (ASA) physical status I-III, scheduled to undergo unilateral hip surgery.\n\nExclusion Criteria:\n\n* History of neurological/neuromuscular, psychiatric disease, dementia preventing proper comprehension.\n* Patients with Body Mass Index (BMI) \\<18.5 or \\>30 kg/m2.\n* Coagulation disturbances (INR\\>1.4, platelet count\\<100 000).\n* History of opioid dependence (opioid use within the last 4 weeks).\n* History of allergies to study medications.'}, 'identificationModule': {'nctId': 'NCT03733769', 'briefTitle': 'A Novel Approach for Transmuscular Quadratus Lumborum Block', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'A Novel Approach for Transmuscular Quadratus Lumborum Block for Peri-operative Analgesia in Hip Surgery', 'orgStudyIdInfo': {'id': 'TQL block in hip surgery'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TQL group', 'description': 'transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery', 'interventionNames': ['Procedure: transmuscular quadratus lumborum block']}], 'interventions': [{'name': 'transmuscular quadratus lumborum block', 'type': 'PROCEDURE', 'description': 'transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery', 'armGroupLabels': ['TQL group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21131', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria Faculty of Medicine', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Emad A Abdelmonem', 'role': 'STUDY_CHAIR', 'affiliation': 'Alexandria faculty of medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer of anaesthesiology', 'investigatorFullName': 'Ahmad Samir Alabd', 'investigatorAffiliation': 'Alexandria University'}}}}