Ignite Creation Date:
2025-12-25 @ 2:42 AM
Ignite Modification Date:
2025-12-31 @ 10:25 PM
Study NCT ID:
NCT04367233
Status:
UNKNOWN
Last Update Posted:
2023-10-31
First Post:
2020-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quadratus Lumborum Block Versus Transversus Abdominis Block
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000768', 'term': 'Anesthesia, General'}], 'ancestors': [{'id': 'D000758', 'term': 'Anesthesia'}, {'id': 'D000760', 'term': 'Anesthesia and Analgesia'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': "A professional who will not participate in other stages of the study will conduct the drawing and envelopes preparation.\n\nMasking: at the end of the surgery, the anesthesiologist will perform the blocking corresponding to the patient's group and will not participate in other stages of the study. A professional who does not know the group to which each patient belongs will perform the collection and analysis of the endpoint variables."}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Prospective, controlled, randomized and double blinded.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-30', 'studyFirstSubmitDate': '2020-04-21', 'studyFirstSubmitQcDate': '2020-04-28', 'lastUpdatePostDateStruct': {'date': '2023-10-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Morphine consumption', 'timeFrame': '12 hours', 'description': 'Consumption of morphine in the postoperative period,during hospital stay'}, {'measure': 'Codeine consumption', 'timeFrame': 'Two days', 'description': 'Consumption of codeine during the 48 hours following the surgery'}], 'secondaryOutcomes': [{'measure': 'Postoperative pain', 'timeFrame': 'Two days', 'description': 'Pain scores on awaking, 6 hours after, and during the first 2 postoperative days, based on verbal pain score, ranging 0 (without pain) to 10 (worst imaginable pain)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain']}, 'referencesModule': {'references': [{'pmid': '19275847', 'type': 'BACKGROUND', 'citation': 'Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. JSLS. 2008 Oct-Dec;12(4):351-7. No abstract available.'}, {'pmid': '30688787', 'type': 'BACKGROUND', 'citation': 'Elsharkawy H, El-Boghdadly K, Barrington M. Quadratus Lumborum Block: Anatomical Concepts, Mechanisms, and Techniques. Anesthesiology. 2019 Feb;130(2):322-335. doi: 10.1097/ALN.0000000000002524. No abstract available.'}, {'pmid': '30975950', 'type': 'BACKGROUND', 'citation': 'Suner ZC, Kalayci D, Sen O, Kaya M, Unver S, Oguz G. Postoperative analgesia after total abdominal hysterectomy: Is the transversus abdominis plane block effective? Niger J Clin Pract. 2019 Apr;22(4):478-484. doi: 10.4103/njcp.njcp_61_15.'}, {'pmid': '29723644', 'type': 'BACKGROUND', 'citation': 'Bacal V, Rana U, McIsaac DI, Chen I. Transversus Abdominis Plane Block for Post Hysterectomy Pain: A Systematic Review and Meta-Analysis. J Minim Invasive Gynecol. 2019 Jan;26(1):40-52. doi: 10.1016/j.jmig.2018.04.020. Epub 2018 Apr 30.'}, {'pmid': '31649394', 'type': 'BACKGROUND', 'citation': 'Verma K, Malawat A, Jethava D, Jethava DD. Comparison of transversus abdominis plane block and quadratus lumborum block for post-caesarean section analgesia: A randomised clinical trial. Indian J Anaesth. 2019 Oct;63(10):820-826. doi: 10.4103/ija.IJA_61_19. Epub 2019 Oct 10.'}, {'pmid': '20221641', 'type': 'BACKGROUND', 'citation': 'Ferreira KA, Teixeira MJ, Mendonza TR, Cleeland CS. Validation of brief pain inventory to Brazilian patients with pain. Support Care Cancer. 2011 Apr;19(4):505-11. doi: 10.1007/s00520-010-0844-7. Epub 2010 Mar 10.'}]}, 'descriptionModule': {'briefSummary': 'The advent of laparotomy replacement by minimally invasive techniques brought the obvious benefit of postoperative pain reduction. The application of transversus abdominis block has already demonstrated to reduce postoperative pain in laparoscopic hysterectomy. The comparison between it and quadratus lumborum block in cesarean sections showed that the latter was superior in relation to postoperative analgesia. The aim of this trial is to compare postoperative analgesia in patients receiving one or the other of these regional anesthesia techniques to prevent postoperative pain in gynecological laparoscopic surgeries. The recruited sample will be randomly distributed in three groups to receive placebo, transverse abdominal plan block or quadratus lumborum block, in a covert way for the patients and team. The primary outcome evaluated will be the postoperative consumption of opioid and the secondary outcome will be the evaluation of postoperative pain scores.', 'detailedDescription': ': the sample will be divided into three groups and all participants will receive general anesthesia. Patients in the placebo group (PG) will be referred to the post-anesthesia recovery room after extubation and adequate hemodynamic and respiratory recovery. Patients in the tap block group (TBG) will receive 0.2 ml of 0.25% ropivacaine between the transverse and oblique internal muscles guided by ultrasound (US), on one side and after the other (the same dose), after the end of surgery. Patients in the quadratus lumborum group (LQG) will receive 0.2 ml/kg of 0.25% ropivacaine inside the middle layer of the thoracolumbar fascia guided by US, on one side and after the other (the same dose), after the end of the surgery. In all participants, the monitoring will include cardioscope, oximetry, non-invasive blood pressure and monitor of hypnoses level. After peripheral venous puncture, antibiotic prophylaxis with 2g cefazolin, and pre-anesthetic medication with midazolam 0.05 mg/kg. After 5 min pre-oxygenation, the patients will receive venous anesthetic induction with 2% lidocaine 1mg/kg without vasoconstrictor; fentanyl 4 µ/kg; propofol 2 mg/kg, or even adequate hypnosis guided by proper monitor; cisatracurium 0.15mg/kg, with tracheal intubation and mechanical ventilation after anesthetic plan confirmed with proper monitor and adequate muscle relaxation. Anesthesia will be maintained with propofol in continuous infusion guided by hypnoses monitor and remifentanil in continuous infusion between 0.1 and 0.5 µg/kg/min, according to patient need. All study participants will receive ondansetron 8 mg, dipyrone 2 g, ketoprofen 100 mg, dexamethasone 10 mg and morphine 3 mg. At the end of the surgery, after partial recovery from neuromuscular blockade, patients will receive atropine 0.01 mg/kg and neostigmine: 0.02mg/kg before tracheal extubation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Scheduled to gynecological video laparoscopy.\n\nExclusion Criteria:\n\n* Allergy to any component of the study protocol, coagulopathies.'}, 'identificationModule': {'nctId': 'NCT04367233', 'briefTitle': 'Quadratus Lumborum Block Versus Transversus Abdominis Block', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Quadratus Lumborum Block Versus Transversus Abdominis Block . Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'CAAE 28763119.0.0000.5448'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo group', 'description': 'General anesthesia with fentanyl, propofol and remifentanyl', 'interventionNames': ['Other: General anesthesia']}, {'type': 'EXPERIMENTAL', 'label': 'Transverse block group', 'description': 'At the end of general anesthesia with fentanyl, propofol and remifentanil, the patient will receive transverse plan block, with ropivacaine 0,25% 0,2 ml/kg.', 'interventionNames': ['Other: Transverse abdominal block']}, {'type': 'EXPERIMENTAL', 'label': 'Quadratus lumborum group', 'description': 'At the end of general anesthesia with fentanyl, propofol and remifentanil, the patient will receive quadratus lumborum block with ropivacaine 0,25% 0,2 ml/kg.', 'interventionNames': ['Other: Quadratus lumborum block']}], 'interventions': [{'name': 'General anesthesia', 'type': 'OTHER', 'description': 'General anesthesia with fentanyl, propofol and remifentanil.', 'armGroupLabels': ['Placebo group']}, {'name': 'Transverse abdominal block', 'type': 'OTHER', 'description': 'Transverse abdominal block with ropivacaine 0,25% 0,2 ml/kg at the end of general anesthesia with fentanyl, propofol and remifentanil', 'armGroupLabels': ['Transverse block group']}, {'name': 'Quadratus lumborum block', 'type': 'OTHER', 'description': 'At the end of general anesthesia with fentanyl, propofol and remifentanil, patients will receive quadratus lumborum block with ropivacaine 0,25% 0,2 ml/kg', 'armGroupLabels': ['Quadratus lumborum group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246-903', 'city': 'São Paulo', 'country': 'Brazil', 'contacts': [{'name': 'joaquim vieira, MD', 'role': 'CONTACT', 'email': 'joaquimve@usp.br', 'phone': '55-11-30618716'}, {'name': 'Sebastião Silva Filho, Physician', 'role': 'CONTACT', 'email': 'sebasernesto@gmail.com', 'phone': '12991457764'}], 'facility': 'Hospital das Clínicas - Faculdade de Medicina da Universidade de Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'sebastião ernesto', 'role': 'CONTACT', 'email': 'sebasernesto@gmail.com', 'phone': '12991457764'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Joaquim Edson Vieira', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}