Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-01-07 @ 6:50 AM
Study NCT ID:
NCT03545295
Status:
UNKNOWN
Last Update Posted:
2018-06-04
First Post:
2018-05-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Determination Of Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'the cadavers will be randomized to receive the intervention (Quadratus Lumborum Block) by different techniques (QLB 2/ QLB3) and different volumes (10, 20, 30 ml)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2019-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-05-22', 'studyFirstSubmitDate': '2018-05-12', 'studyFirstSubmitQcDate': '2018-05-22', 'lastUpdatePostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Spread of coloring solution according to the volume injected', 'timeFrame': '3 hours', 'description': 'Observation of coloring solution around the spinal nerves as they exit the vertebral foramen. Comparison of number of spinal nerves colored according to the volume injected.'}], 'secondaryOutcomes': [{'measure': 'Spread of coloring solution to the paravertebral space', 'timeFrame': '3 hours', 'description': 'Observation of coloring solution on the paravertebral space. Comparison of spread to the paravertebral space according to the volume injected.'}, {'measure': 'Comparison of spread of the coloring solution between QLB 2 and QLB3', 'timeFrame': '3 hours', 'description': 'Observation of coloring solution around the spinal nerves as they exit the vertebral foramen and spread to the paravertebral space. Comparison of number of spinal nerves colored according to the technique used.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nerve Block']}, 'referencesModule': {'references': [{'pmid': '27755488', 'type': 'BACKGROUND', '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.'}, {'pmid': '26225500', 'type': 'BACKGROUND', 'citation': 'Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.'}, {'pmid': '26735154', 'type': 'BACKGROUND', 'citation': 'Murouchi T, Iwasaki S, Yamakage M. Quadratus Lumborum Block: Analgesic Effects and Chronological Ropivacaine Concentrations After Laparoscopic Surgery. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):146-50. doi: 10.1097/AAP.0000000000000349.'}, {'pmid': '29389680', 'type': 'BACKGROUND', 'citation': 'Tamura T, Kitamura K, Yokota S, Ito S, Shibata Y, Nishiwaki K. Spread of Quadratus Lumborum Block to the Paravertebral Space Via Intramuscular Injection: A Volunteer Study. Reg Anesth Pain Med. 2018 May;43(4):372-377. doi: 10.1097/AAP.0000000000000735.'}, {'pmid': '29491513', 'type': 'BACKGROUND', 'citation': 'Wahal C, Kumar A, Pyati S. Advances in regional anaesthesia: A review of current practice, newer techniques and outcomes. Indian J Anaesth. 2018 Feb;62(2):94-102. doi: 10.4103/ija.IJA_433_17.'}, {'pmid': '28731927', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, El-Boghdadly K, Kolli S, Esa WAS, DeGrande S, Soliman LM, Drake RL. Injectate spread following anterior sub-costal and posterior approaches to the quadratus lumborum block: A comparative cadaveric study. Eur J Anaesthesiol. 2017 Sep;34(9):587-595. doi: 10.1097/EJA.0000000000000680.'}, {'pmid': '28277325', 'type': 'BACKGROUND', 'citation': 'Dam M, Moriggl B, Hansen CK, Hoermann R, Bendtsen TF, Borglum J. The Pathway of Injectate Spread With the Transmuscular Quadratus Lumborum Block: A Cadaver Study. Anesth Analg. 2017 Jul;125(1):303-312. doi: 10.1213/ANE.0000000000001922.'}, {'pmid': '28098413', 'type': 'BACKGROUND', 'citation': 'Hernandez MA, Vecchione T, Boretsky K. Dermatomal spread following posterior transversus abdominis plane block in pediatric patients: our initial experience. Paediatr Anaesth. 2017 Mar;27(3):300-304. doi: 10.1111/pan.13034. Epub 2017 Jan 18.'}, {'pmid': '28759502', 'type': 'BACKGROUND', 'citation': 'Oksuz G, Bilal B, Gurkan Y, Urfalioglu A, Arslan M, Gisi G, Oksuz H. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block in Children Undergoing Low Abdominal Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2017 Sep/Oct;42(5):674-679. doi: 10.1097/AAP.0000000000000645.'}, {'pmid': '28802593', 'type': 'BACKGROUND', 'citation': 'Ishio J, Komasawa N, Kido H, Minami T. Evaluation of ultrasound-guided posterior quadratus lumborum block for postoperative analgesia after laparoscopic gynecologic surgery. J Clin Anesth. 2017 Sep;41:1-4. doi: 10.1016/j.jclinane.2017.05.015. Epub 2017 Jun 1.'}, {'pmid': '29195100', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H. RETRACTED: Clinical experiences of unilateral anterior sub-costal quadratus lumborum block for a nephrectomy. J Clin Anesth. 2018 Feb;44:120. doi: 10.1016/j.jclinane.2017.11.031. Epub 2017 Nov 29. No abstract available.', 'retractions': [{'pmid': '35393174', 'source': 'J Clin Anesth. 2022 Aug;79:110749'}]}, {'pmid': '28802611', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Hiroshi O. RETRACTED: Lumbar vertebra surgery performed with a bilateral posterior quadratus lumborum block. J Clin Anesth. 2017 Sep;41:61. doi: 10.1016/j.jclinane.2017.06.012. Epub 2017 Jul 3. No abstract available.', 'retractions': [{'pmid': '35396108', 'source': 'J Clin Anesth. 2022 Aug;79:110790'}]}, {'pmid': '28609336', 'type': 'BACKGROUND', 'citation': 'Ben-David B, La Colla L. Extravasated Fluid in Hip Arthroscopy and Pain: Is Quadratus Lumborum Block the Answer? Anesth Analg. 2017 Jul;125(1):364. doi: 10.1213/ANE.0000000000002198. No abstract available.'}, {'pmid': '19462494', 'type': 'BACKGROUND', 'citation': 'Gehling M, Tryba M. Risks and side-effects of intrathecal morphine combined with spinal anaesthesia: a meta-analysis. Anaesthesia. 2009 Jun;64(6):643-51. doi: 10.1111/j.1365-2044.2008.05817.x.'}, {'pmid': '21148659', 'type': 'BACKGROUND', 'citation': 'Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.'}, {'pmid': '28235508', 'type': 'BACKGROUND', 'citation': 'Ueshima H, Otake H. RETRACTED: Lower limb amputations performed with anterior quadratus lumborum block and sciatic nerve block. J Clin Anesth. 2017 Feb;37:145. doi: 10.1016/j.jclinane.2016.12.026. Epub 2017 Jan 10. No abstract available.', 'retractions': [{'pmid': '35393170', 'source': 'J Clin Anesth. 2022 Aug;79:110743'}]}]}, 'descriptionModule': {'briefSummary': 'Lumbar Quadrant Blockade is a recent analgesic technique consisting of the injection of local anesthetic around the lumbar square muscle. It was initially described as a technique for abdominal wall analgesia, but later studies have increased the range of indications for laparoscopic and lower limb surgeries. There are several techniques described but with differences in the literature at the point of injection and volume of anesthetic. The exact mechanism of visceral analgesia has not yet been determined. The objective of this study is to determine the dispersion of local anesthetic as a variable dependent on the volume of local anesthetic and injection site and elucidate the mechanisms of analgesia.', 'detailedDescription': 'After the free and informed consent signed by the family authorizing the procedure, demographic and clinical data will be collected from the medical records of the deceased. The corpse will be weighed, measured and placed on the autopsy table. Blockade randomization (QLB 2 or QLB 3) and volume of local anesthetic (10ml, 20ml, 30ml) will be performed for each side. Injection in the anterior or posterior plane to the Lumbar Quadrant muscle will be performed by anesthesiologists experienced in the technique with ultrasound aid. A colouring solution will be used. After confirming the correct needle position, the previously randomized volumes will be injected. After the blockage, the corpse will be placed in the supine position and will be submitted to autopsy by standard procedure. After removal of the thoracic and abdominal viscera, the investigators will verify the dispersion of the local anesthetic. Photographic records will be made and the number of levels by which the solution dispersed will be annotated, calculating the number of cranial and caudal levels. The corpse will then have its autopsy procedure completed, with the placement of the viscera and incision closure according to the service standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Fresh corpses - not subjected to a formaldehyde process or frozen for more than 24 hours\n* Age ≥ 18 years.\n* Free, informed and informed consent signed by relatives or guardians of the body.\n* Height\\> 150 cm and \\<190 cm\n\nExclusion Criteria:\n\n* Previous spinal surgery.\n* Significant spinal deformity\n* Body mass index (BMI) ≥ 35 kg / m2\n* Absence of relatives or guardians who can sign the written consent'}, 'identificationModule': {'nctId': 'NCT03545295', 'briefTitle': 'Determination Of Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of São Paulo'}, 'officialTitle': 'Determination Of The Relationship Between Local Anesthetic Volume And Its Dispersion In Ultrasound Guided Quadratus Lumborum Block In Cadavers', 'orgStudyIdInfo': {'id': 'Quadratus Lumborum Block'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLB 2 10ml', 'description': 'The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 10 ml coloring solution', 'interventionNames': ['Procedure: Quadratus Lumborum Block type 2']}, {'type': 'EXPERIMENTAL', 'label': 'QLB 2 20ml', 'description': 'The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 20 ml coloring solution', 'interventionNames': ['Procedure: Quadratus Lumborum Block type 2']}, {'type': 'EXPERIMENTAL', 'label': 'QLB 2 30ml', 'description': 'The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 2 with 30 ml coloring solution', 'interventionNames': ['Procedure: Quadratus Lumborum Block type 2']}, {'type': 'EXPERIMENTAL', 'label': 'QLB 3 10ml', 'description': 'The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 10 ml coloring solution', 'interventionNames': ['Procedure: Quadratus Lumborum Block type 3']}, {'type': 'EXPERIMENTAL', 'label': 'QLB 3 20ml', 'description': 'The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 20 ml coloring solution', 'interventionNames': ['Procedure: Quadratus Lumborum Block type 3']}, {'type': 'EXPERIMENTAL', 'label': 'QLB 3 30ml', 'description': 'The cadaver will receive an ultrasound- guided Quadratus Lumborum Block type 3 with 30 ml coloring solution', 'interventionNames': ['Procedure: Quadratus Lumborum Block type 3']}], 'interventions': [{'name': 'Quadratus Lumborum Block type 2', 'type': 'PROCEDURE', 'description': 'Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle', 'armGroupLabels': ['QLB 2 10ml', 'QLB 2 20ml', 'QLB 2 30ml']}, {'name': 'Quadratus Lumborum Block type 3', 'type': 'PROCEDURE', 'description': 'Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle', 'armGroupLabels': ['QLB 3 10ml', 'QLB 3 20ml', 'QLB 3 30ml']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01221020', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'Marcelo V Perez, PhD', 'role': 'CONTACT', 'email': 'marcelovazperez@gmail.com'}, {'name': 'Marilia Tassinari Gonçalves Preza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andre L Valsecchi Casale, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Irmandade de Misericórdia da Santa Casa De São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Marcelo V Perez, PhD', 'role': 'CONTACT', 'email': 'marcelovazperez@gmail.com', 'phone': '+551121767000'}], 'overallOfficials': [{'name': 'Marilia Tassinari Gonçalves Preza, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Post Graduate'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The research results will be published in indexed scientific journals, maintaining participants identity confidential'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Irmandade da Santa Casa de Misericordia de Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Médico Assistente', 'investigatorFullName': 'Marcelo Vaz Perez', 'investigatorAffiliation': 'Federal University of São Paulo'}}}}