Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2026-02-26 @ 8:11 PM
Study NCT ID:
NCT02121951
Status:
WITHDRAWN
Last Update Posted:
2018-04-10
First Post:
2014-04-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block for Percutaneous Nephrostomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001733', 'term': 'Bites and Stings'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D011041', 'term': 'Poisoning'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008012', 'term': 'Lidocaine'}, {'id': 'D000077554', 'term': 'Levobupivacaine'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D002045', 'term': 'Bupivacaine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2014-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-08', 'studyFirstSubmitDate': '2014-04-20', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2018-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analgesia', 'timeFrame': '4 hours', 'description': 'Verbal Rating Scale is assessed for degree of pain during the procedure and after till discharge from the radiology department.'}], 'secondaryOutcomes': [{'measure': 'Respiratory Depression', 'timeFrame': '4 hours', 'description': 'Respiratory rate and airway patency is monitored with an anesthesiologist.'}, {'measure': 'Sedation', 'timeFrame': '4 hours', 'description': 'Ramsay Seadation Score is assessed during and after procedure till discharge'}, {'measure': 'Cardiovascular stability', 'timeFrame': '4 hours', 'description': 'Blood pressure and Heart rate is assessed during and after procedure till discharge'}, {'measure': 'Patient Satisfaction', 'timeFrame': '48 hours', 'description': 'Patient Satisfaction Quistionaire'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Percutaneous Nephrostomy', 'Quadtatus Lumborum Block', 'Cancer', 'Monitored Anaesthesia Care'], 'conditions': ['Nephrostomy; Complications', 'Upper Urinary Tract Dilatation and Obstruction', 'Regional Anesthesia Morbidity', 'Adverse Anesthesia Outcome']}, 'referencesModule': {'references': [{'pmid': '24249997', 'type': 'RESULT', 'citation': 'Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.'}, {'pmid': '24310051', 'type': 'RESULT', 'citation': 'Ironfield CM, Barrington MJ, Kluger R, Sites B. Are patients satisfied after peripheral nerve blockade? Results from an International Registry of Regional Anesthesia. Reg Anesth Pain Med. 2014 Jan-Feb;39(1):48-55. doi: 10.1097/AAP.0000000000000038.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous nephrostomy (PCN) is one of the interventions in the radiology department in which pain control is necessary. Quadratus Lumborum (QL) block will be tried to limit the use of systemic analgesics and its accompanying untoward effects in those frail patients requiring PCN that is performed in the prone position.', 'detailedDescription': "Quadratus Lumborum block is a novel technique in which extension into the thoracic paravertebral space may occur. QL block would seem to be able to alleviate both somatic and visceral pain so it's expected to decrease the need for systemic sedation\\\\analgesia to a minimum."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ASA grade III and IV patients,\n2. Ureteral obstruction due to malignancy or secondary to urinary diversion after cystectomy\n\nExclusion Criteria:\n\n1. Bleeding diathesis; INR more than than 1.5 and platelet count less than 100,000/mm3.\n2. Untreated urinary tract infection;\n3. Pre-operative haemoglobin \\<10 gm/dl,\n4. Severely co morbid patients\n5. Non-dilated renal collecting system\n6. Patient refusal to consent for the procedure.'}, 'identificationModule': {'nctId': 'NCT02121951', 'acronym': 'QLB', 'briefTitle': 'Quadratus Lumborum Block for Percutaneous Nephrostomy', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Institute, Egypt'}, 'officialTitle': 'Quadratus Lumborum Block Versus Local Anesthetic Infiltration Combined With Monitored Anesthesia Care for Percutaneous Nephrostomy', 'orgStudyIdInfo': {'id': 'Quadratus Lumborum Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Local Anesthetic infiltration and MAC', 'description': '* Local Anesthetic infiltration with 1% lignocaine\n* MAC with IV Midazolam Img\\\\ml and Fentanyl 10 mic\\\\ml', 'interventionNames': ['Procedure: Local Anesthetic infiltration', 'Drug: MAC']}, {'type': 'EXPERIMENTAL', 'label': 'Quadratus Lumborum block and MAC', 'description': '* QL block with 0.25% levobupivacaine (Chirocaine, Abbott, Ireland) and 1% lignocaine\n* MAC with IV Midazolam Img\\\\ml and Fentanyl 10 mic\\\\ml', 'interventionNames': ['Procedure: Quadratus Lumborum block', 'Drug: MAC']}], 'interventions': [{'name': 'Local Anesthetic infiltration', 'type': 'PROCEDURE', 'otherNames': ['Lignocaine'], 'description': 'Lignocaine infiltration through the nephrostomy track', 'armGroupLabels': ['Local Anesthetic infiltration and MAC']}, {'name': 'Quadratus Lumborum block', 'type': 'PROCEDURE', 'otherNames': ['-0.25% levobupivacaine (Chirocaine, Abbott, Ireland)', '-1% lignocaine'], 'description': 'A linear 12-MHz ultrasound probe will be placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this point the layers of abdominal layers starte to taper. The probe will be placed in the posterior axillary line, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL will be noticed. At the posterior border of the quadratus lumborum muscle and outside the fascia, Touhe needle will be inserted in plane and confirmed its position by injecting saline. Under ultrasound (US) guidance, local anesthetic mixure will be deposited separating the fascia', 'armGroupLabels': ['Quadratus Lumborum block and MAC']}, {'name': 'MAC', 'type': 'DRUG', 'otherNames': ['-Midazolam: 1 mg\\ml', '-Fentanyl: 10 mic\\ml'], 'description': 'Incremental doses are given to the targed sedation and analgesia', 'armGroupLabels': ['Local Anesthetic infiltration and MAC', 'Quadratus Lumborum block and MAC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11796', 'city': 'Cairo', 'state': 'Old Cairo', 'country': 'Egypt', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Dina N Abbas, M D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National Cancer Institute, Egypt'}, {'name': 'Ghada M Bashandy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute, Egypt'}, {'name': 'Wael Darwish, M D', 'role': 'STUDY_CHAIR', 'affiliation': 'National Cancer Institute, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute, Egypt', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr', 'investigatorFullName': 'Ghada M N Bashandy', 'investigatorAffiliation': 'National Cancer Institute, Egypt'}}}}