Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-01-01 @ 6:38 PM
Study NCT ID:
NCT06838156
Status:
COMPLETED
Last Update Posted:
2025-02-20
First Post:
2025-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery
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': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, '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': '2023-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-18', 'studyFirstSubmitDate': '2025-02-09', 'studyFirstSubmitQcDate': '2025-02-18', 'lastUpdatePostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect on pain score', 'timeFrame': 'At 1,2,4, 6, 12 and 24 hours after surgery', 'description': 'Postoperative 24-hour Visual Analog Scale was measured. ( 0=best 10=worst)'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': 'At 1,2,4, 6, 12 and 24 hours after surgery', 'description': 'Intravenous patient-controlled analgesia (PCA) with tramadol was administered to both groups in the postoperative period.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Opioid Consumption', 'Pain Postoperative']}, 'referencesModule': {'references': [{'pmid': '38762396', 'type': 'BACKGROUND', 'citation': 'Safa B, Trinh H, Lansdown A, McHardy PG, Gollish J, Kiss A, Kaustov L, Choi S. Ultrasound-guided suprainguinal fascia iliaca compartment block and early postoperative analgesia after total hip arthroplasty: a randomised controlled trial. Br J Anaesth. 2024 Jul;133(1):146-151. doi: 10.1016/j.bja.2024.04.019. Epub 2024 May 18.'}, {'pmid': '34243719', 'type': 'BACKGROUND', 'citation': 'Xia Q, Ding W, Lin C, Xia J, Xu Y, Jia M. Postoperative pain treatment with transmuscular quadratus lumborum block and fascia iliaca compartment block in patients undergoing total hip arthroplasty: a randomized controlled trial. BMC Anesthesiol. 2021 Jul 10;21(1):188. doi: 10.1186/s12871-021-01413-7.'}]}, 'descriptionModule': {'briefSummary': "Total Hip Arthroplasty (THA) is a complex surgical procedure frequently performed to treat degenerative conditions in the hip joint. As people's life expectancy increases, the need for hip arthroplasty increases. İnvestigetors aimed to compare the analgesic properties of SIFI and QLB blocks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective patients scheduled for hip arthroplasty surgery\n2. Patient willingness to participate in the study\n3. Patients over 18 years age of, ASA I-II-III,\n\nExclusion Criteria:\n\n1. Patients not wanting to participate in the study\n2. Patients who do not want regional anesthesia technique\n3. Allergic or coagulated patients\n4. Patients with liver, kidney, lung, heart failure and septic patients\n5. Neurological disorder, history of convulsions\n6. ASA IV patients'}, 'identificationModule': {'nctId': 'NCT06838156', 'briefTitle': 'Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Comparison of Analgesic Efficacy of Quadratus Lumborum Type 3 and Suprainguinal Fascia Iliaca Compartment Block in Total Hip Arthroplasty Surgery: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'GK-QLB-SIFI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'SIFI Group', 'description': 'Group of 30 patients who underwent SIFI block', 'interventionNames': ['Drug: Bupivacain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'QLB Type 3', 'description': 'Group of 30 patients who underwent QLB block', 'interventionNames': ['Drug: Bupivacain']}], 'interventions': [{'name': 'Bupivacain', 'type': 'DRUG', 'otherNames': ['SIFI'], 'description': 'Suprainguinal Fascia Iliaca Compartment block was performed with a linear probe placed over the inguinal ligament using a portable ultrasound device. After visualization of the femoral nerve, 30 ml of 0.25% bupivacaine was injected into the fascia iliaca overlying the iliopsoas muscle using an appropriate needle.', 'armGroupLabels': ['SIFI Group']}, {'name': 'Bupivacain', 'type': 'DRUG', 'otherNames': ['QLB Type 3'], 'description': 'Quadratus Lumborum Type 3 block was performed using a portable ultrasound device with a linear probe placed between the costal margin and the iliac crest on the lateral abdominal wall. 30 ml of 0.25% bupivacaine was injected between the quadratus lumborum and psoas muscles using an appropriate needle.', 'armGroupLabels': ['QLB Type 3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Başakşehir', 'state': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Başakşehir Çam Ve Sakura City Hospital', 'geoPoint': {'lat': 41.106, 'lon': 28.791}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor Doctor', 'investigatorFullName': 'Muzaffer GENCER', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}