Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-26 @ 2:32 AM
Study NCT ID:
NCT04800302
Status:
COMPLETED
Last Update Posted:
2022-07-22
First Post:
2021-03-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D053040', 'term': 'Nephrolithiasis'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052878', 'term': 'Urolithiasis'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-21', 'studyFirstSubmitDate': '2021-03-12', 'studyFirstSubmitQcDate': '2021-03-15', 'lastUpdatePostDateStruct': {'date': '2022-07-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption.', 'timeFrame': '24 hours', 'description': 'Total dose of Morphine (measured in mg) given intra-venously to the patient post-operatively.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Quadratus Lumborum Block III', 'Ultrasound-guided', 'Percutaneous nephrolithotomy', 'Analgesia'], 'conditions': ['Analgesia', 'Surgery', 'Renal Stone']}, 'descriptionModule': {'briefSummary': "Percutaneous nephrolithotomy (PCNL) is considered to be the first choice and a more conservative procedure than open stone surgery. Not only postoperative pain related to dilatation of the renal capsule and parenchymal tract, but also patient's discomfort \\& nephrostomy tube-related stress are reported to delay recovery time and increase the complication rates. This study is designed to provide postoperative analgesia by using ultrasound-guided continuous Quadratus Lumborum Block (QLB) III in patients undergoing PCNL and to assess pain scores \\& side effects with less opioids consumption."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA I-II.\n* Scheduled for percutaneous nephrolithotomy (PCNL).\n\nExclusion Criteria:\n\n* Patient refusal.\n* Coagulation disorders.\n* Skin lesions or infection at site of needle insertion.\n* Known allergy to local anesthetics or opioids.\n* Patients suffering from neurological or mental disease.\n* Procedure turned into open stone surgery.\n* Failure of identification by U/S.\n* Urinary tract malignancies.\n* Opioid consumption 48 hours before the operation.'}, 'identificationModule': {'nctId': 'NCT04800302', 'briefTitle': 'U/S-guided Continuous Quadratus Lumborum Block III in Percutaneous Nephrolithotomy', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Ultrasound-guided Continuous Quadratus Lumborum Block III for Postoperative Analgesia in Percutaneous Nephrolithotomy', 'orgStudyIdInfo': {'id': 'USGCQLBIIIPCNL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous QLB group', 'description': 'U/S-guided continous QLB III', 'interventionNames': ['Procedure: Continous Quadratum Lumborum Block III', 'Procedure: Single dose Quadratum Lumborum Block III', 'Procedure: Intra-venous Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single dose QLB group', 'description': 'U/S-guided single dose QLB III', 'interventionNames': ['Procedure: Single dose Quadratum Lumborum Block III', 'Procedure: Intra-venous Morphine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Morphine group', 'description': 'IV Morphine', 'interventionNames': ['Procedure: Intra-venous Morphine']}], 'interventions': [{'name': 'Continous Quadratum Lumborum Block III', 'type': 'PROCEDURE', 'description': 'Continuous infusion of Bupivacaine 0.125 % at a rate of 0.1 ml/kg/hr (not exceeding 12 ml/hour), infused through a catheter inserted in the plane between quadratus lumborum \\& psoas major muscles with ultrasound guidance.', 'armGroupLabels': ['Continuous QLB group']}, {'name': 'Single dose Quadratum Lumborum Block III', 'type': 'PROCEDURE', 'description': 'Single injection of a mixture solution of 20 ml Bupivacaine 0.5% + 10 ml Lidocaine 2%, injected through a needle inserted at the posterior aspect of the quadratus lumborum muscle between it and erector spinae muscle with ultrasound guidance.', 'armGroupLabels': ['Continuous QLB group', 'Single dose QLB group']}, {'name': 'Intra-venous Morphine', 'type': 'PROCEDURE', 'description': 'Intra-venous Morphine \\[0.1 mg/kg\\] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.', 'armGroupLabels': ['Continuous QLB group', 'Morphine group', 'Single dose QLB group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Sherif A Embaby, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kasr Al-Ainy Hospital, Faculty of Medicine, Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nazmy Edward Seif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Nazmy Edward Seif', 'investigatorAffiliation': 'Cairo University'}}}}