Ignite Creation Date:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2026-04-19 @ 8:12 PM
Study NCT ID:
NCT03100994
Status:
UNKNOWN
Last Update Posted:
2017-04-04
First Post:
2017-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': '3 group: Group A: without intervention; Group B: Ultrasound-guided transmuscular quadratus lumborum block; Group C: Ultrasound-guided quadratus lumborum type II block'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2017-03-24', 'studyFirstSubmitQcDate': '2017-03-29', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': '48 hours', 'description': 'morphine consumption'}], 'secondaryOutcomes': [{'measure': 'Severity of postoperative pain via visual analogue pain scale (VAS)', 'timeFrame': '48 hours', 'description': 'Total cumulative morphine dose in mg used in the first 48 hours after surgery'}, {'measure': 'Nausea or vomiting', 'timeFrame': '48 hours', 'description': 'Severity of nausea or vomiting in the first 48 hours after surgery. Severe :3 Moderate:2 Mild:1 None: 0'}, {'measure': 'time to mobilization', 'timeFrame': '48 hours', 'description': 'Time to mobile in the first 48 hours after surgery'}, {'measure': 'Skin itch', 'timeFrame': '48 hours', 'description': 'Severity of skin itch in the first 48 hours after surgery. Severe :3 Moderate:2 Mild:1 None: 0'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Nerve Block']}, 'referencesModule': {'references': [{'pmid': '27730633', 'type': 'RESULT', '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': '27755488', 'type': 'RESULT', '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': 'Post-operative analgesia efficacy using ultrasound-guided transmuscular quadratus lumborum block versus ultrasound-guided quadratus lumborum type II block', 'detailedDescription': 'The Quadratus Lumborum (QL) Block is an ultrasound-guided technique described by Rafael Blanco in 2007. The nerves to the lower abdominal wall can be anesthetized by injecting local anesthetics between the quadratus lumborum muscle and latissimus dorsi muscle, which is called quadratus lumborum type II block. 〝 Transmuscular quadratus lumborum block demonstrates that injectate spreads over the posterior abdominal wall to the psoas major muscle and includes the upper branches of the lumbar plexus.〞described by Adhikary in 2016. However there are no published reports comparing the 2 techniques. In our study, compared of ultrasound-guided QL2-blocks with transmuscular quadratus lumborum block to investigate analgesic consumption, pain level, opioid related side effects and mobilization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American Society of Anesthesiologists classification (ASA) 1\\~3\n* adequate communication skills\n* Body mass index \\< 32\n\nExclusion Criteria:\n\nchronic pain neurological illness/ neuropathy contraindication against local anesthetics'}, 'identificationModule': {'nctId': 'NCT03100994', 'briefTitle': 'Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.', 'organization': {'class': 'OTHER', 'fullName': 'Tri-Service General Hospital'}, 'officialTitle': 'Post-operative Analgesia Efficacy Using Ultrasound-guided Transmuscular Quadratus Lumborum Block Versus Ultrasound-guided Quadratus Lumborum Type II Block.', 'orgStudyIdInfo': {'id': '1-105-05-157'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A', 'description': 'without nerve block'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Ultrasound guided transmuscular quadratus lumborum block with 0.125% bupivacaine 30ml', 'interventionNames': ['Drug: Bupivacaine', 'Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'Ultrasound guided quadratus lumborum type 2 block with 0.125% bupivacaine 30ml', 'interventionNames': ['Drug: Bupivacaine', 'Device: Ultrasound']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'injecting anesthetics to different local', 'armGroupLabels': ['Group B', 'Group C']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'otherNames': ['Philp'], 'description': 'Ultrasound guided nerve block', 'armGroupLabels': ['Group B', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '114', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Shih-Hua Lin, PhD.', 'role': 'CONTACT'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Hsuan-Cheng Wu, Dr.', 'role': 'CONTACT', 'email': 'aibrain@hotmail.com'}], 'overallOfficials': [{'name': 'Hsuan-Cheng Wu', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tri-Service General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Department of Anesthesiology,Tri-ServiceGeneralHospital', 'investigatorFullName': 'Wu Hsuan-Cheng', 'investigatorAffiliation': 'Tri-Service General Hospital'}}}}