Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-26 @ 1:41 AM
Study NCT ID:
NCT04689633
Status:
COMPLETED
Last Update Posted:
2021-03-04
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2021-04-21', 'releaseDate': '2021-03-26'}, {'resetDate': '2021-06-22', 'releaseDate': '2021-06-01'}, {'resetDate': '2021-08-12', 'releaseDate': '2021-07-19'}, {'resetDate': '2021-10-06', 'releaseDate': '2021-09-09'}], 'estimatedResultsFirstSubmitDate': '2021-03-26'}}, 'interventionBrowseModule': {'meshes': [{'id': 'D009407', 'term': 'Nerve Block'}], 'ancestors': [{'id': 'D000765', 'term': 'Anesthesia, Conduction'}, {'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}, {'id': 'D003714', 'term': 'Denervation'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2020-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-02', 'studyFirstSubmitDate': '2020-12-29', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2021-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time of first postoperative analgesic request', 'timeFrame': '24 hours', 'description': 'first time that patient need analgesia and visual analogue scale more than 3'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Analgesia']}, 'descriptionModule': {'briefSummary': "The patients were randomly allocated into 3 parallel groups of 20 patients in each group by using computer generated tables. group(Q):received bilateral sonar-guided quadratus lumborum bolck using 20 ml bupivacaine 0.25%on each side.group(E): received bilateral ultrasound-guided erector spinae block using 20 ml bupivaciane 0.25%on each side. group(C):didn't received any block", 'detailedDescription': "on arrival to the operative room all patients were monitored with standared monitoring. then IV cannula were inserted. preoxygenation with 100% oxygen and induction of GA by 1mic/kg fentanyl and 2 mg/kg of 1%propofol. endotracheal intubation was facilitated by 0.5mg/kg of atracurium. isoflurane 1-2% with oxygen was used for anesthetic maintenance and 0.15 mg/kg intermittent doses of atracurium to maintain adequate muscle relaxation. ventilation was controlled to maintain end tidal CO2 at 35-40 mmHg and SaO2 between 95-100. after stabilization of the patient's hemodynamics and before surgical incision, quadratus lumborum and erector Spinae block were performed according to patient's group by the same anesthetist with the patient in lateral or prone position respectively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* American society of anesthesiologists(ASA) physical status1and2 scheduled for elective cholecystectomy under general anesthesia\n\nExclusion Criteria:\n\n* Allergy to studed drugs\n* morbid obesity\n* patient refusal\n* infection at the side of the bolck\n* emergency laparoscopic cholecystectomy\n* if laparoscopic procedure converted to open'}, 'identificationModule': {'nctId': 'NCT04689633', 'briefTitle': 'Quadratus Lumborum Block Versus Erector Spinae Block in Laparoscopic Cholecystectomy', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Ultrasound-guided Bilateral Quadratus Lumborum Block Versus Erector Spinae Block for Postoperative Analgesia in Laparoscopic Cholecystectomy', 'orgStudyIdInfo': {'id': '135-12/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Quadratus lumborum block', 'description': 'received bilateral ultrasound-guided Quadratus lumborum block using 20 ml bupivacaine 0.25% on each side', 'interventionNames': ['Procedure: nerve block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Erector spinae block', 'description': 'received bilateral ultrasound-guided erector spinae block using 20 ml bupivacaine 0.25% on each side', 'interventionNames': ['Procedure: nerve block']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': "didn't received any block"}], 'interventions': [{'name': 'nerve block', 'type': 'PROCEDURE', 'description': 'bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest', 'armGroupLabels': ['Erector spinae block', 'Quadratus lumborum block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61111', 'city': 'Minya', 'country': 'Egypt', 'facility': 'Faculty of Medicine', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Abeer Hassaneen, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assistant professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Shadwa Rabea Mohamed', 'investigatorAffiliation': 'Minia University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2021-03-26', 'type': 'RELEASE'}, {'date': '2021-04-21', 'type': 'RESET'}, {'date': '2021-06-01', 'type': 'RELEASE'}, {'date': '2021-06-22', 'type': 'RESET'}, {'date': '2021-07-19', 'type': 'RELEASE'}, {'date': '2021-08-12', 'type': 'RESET'}, {'date': '2021-09-09', 'type': 'RELEASE'}, {'date': '2021-10-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shadwa Rabea Mohamed, Lecturer, Minia University'}}}}