Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT04215705
Status:
COMPLETED
Last Update Posted:
2020-11-06
First Post:
2019-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block III Versus Peritubal Local Infiltration
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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-04', 'studyFirstSubmitDate': '2019-12-28', 'studyFirstSubmitQcDate': '2019-12-30', 'lastUpdatePostDateStruct': {'date': '2020-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative analgesia', 'timeFrame': '24 hours', 'description': 'Postoperative pain measured by visual analogue scale from 0 to 10 measured over 24h where 0 is better and 10 means worst pain'}, {'measure': 'Analgesic requirement', 'timeFrame': '24 hours', 'description': 'Investigators measured the total dose of morphine consumption in mg over 24hour'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'descriptionModule': {'briefSummary': 'Investigators compare post operative analgesic efficacy of peritubal local infiltration versus Quadratus Lumborum Block III . In patients undergoing Percutaneous Nephrolithotomy operation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patient with pelvic renal stone less than 2 cm\n* Americans society of Anesthesiologists physical status I, II\n* BMI\\<35\n\nExclusion Criteria:\n\n* patient refusal to participate in the study\n* Americans society of Anesthesiologists physical status III or above\n* major hepatic, renal or cardiovascular disease\n* BMI \\> 35\n* coagulopathy\n* psychological disorders.'}, 'identificationModule': {'nctId': 'NCT04215705', 'briefTitle': 'Quadratus Lumborum Block III Versus Peritubal Local Infiltration', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Postoperative Analgesic Efficiency of Quadratus Lumborum Block III Versus Peritubal Local Infiltration in Patients Undergoing exPercutaneous Percutaneous Nephrolithotomy Operation : a Randomized Comparative Study', 'orgStudyIdInfo': {'id': 'Post PCNL analgesia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group Q', 'description': 'Patients in this group receive Quadratus Lumborum Block with 20 ml bupivacaine 0.5%', 'interventionNames': ['Procedure: Quadratus block versus peritubal local infiltration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group L', 'description': "Patients in this group receive peritubal local infiltration at 6 and 12 o'clock position with 20ml bupivacaine 0.5%", 'interventionNames': ['Procedure: Quadratus block versus peritubal local infiltration']}], 'interventions': [{'name': 'Quadratus block versus peritubal local infiltration', 'type': 'PROCEDURE', 'description': 'Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation', 'armGroupLabels': ['Group L', 'Group Q']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'state': 'Abbasya', 'country': 'Egypt', 'facility': 'Ain Shams University hosptal', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'url': 'http://www.synapse.org', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR'], 'timeFrame': 'Over 6\n\nWithin 6 month', 'ipdSharing': 'YES', 'description': 'Upon request from Corresponding Author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'simon Halim Armanious', 'investigatorAffiliation': 'Ain Shams University'}}}}