[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602937":3},{"organization":4,"armGroups":7,"interventions":42,"overallOfficials":61,"centralContacts":90,"locations":98,"responsibleParty":110,"collaborators":48,"id":113,"slug":114,"hasResults":115,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":48,"eligibilityCriteria":119,"healthyVolunteers":115,"sex":120,"minAge":121,"maxAge":48,"enrollmentInfo":122,"targetDuration":48,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":137,"overallStatus":148,"whyStopped":48,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"University Hospital of Split","OTHER",[8,14,18,22,27,31,34,38],{"label":9,"type":10,"description":11,"interventionNames":12},"Intracapsular hip fracture FEMORAL BLOCK","ACTIVE_COMPARATOR","Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.",[13],"Procedure: FN and LFCN peripheral nerve blocks with spinal anesthesia",{"label":15,"type":10,"description":11,"interventionNames":16},"Intracapsular hip fracture PENG BLOCK",[17],"Procedure: PENG and LFCN peripheral nerve blocks with spinal anesthesia",{"label":19,"type":10,"description":11,"interventionNames":20},"Intracapsular hip fracture FASCIA ILIACA BLOCK",[21],"Procedure: FIC peripheral nerve block with spinal anesthesia",{"label":23,"type":10,"description":24,"interventionNames":25},"Intracapsular hip fracture FENTANYL","Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for partial endoprothesis of hip fracture.",[26],"Procedure: Fentanyl (IV) with spinal anesthesia",{"label":28,"type":10,"description":29,"interventionNames":30},"Extracapsular hip fracture FEMORAL BLOCK","Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture.",[13],{"label":32,"type":10,"description":29,"interventionNames":33},"Extracapsular hip fracture PENG BLOCK",[17],{"label":35,"type":10,"description":36,"interventionNames":37},"Extracapsular hip fracture FASCIA ILIACA BLOCK","Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for osteosinthesis of hip fracture.",[21],{"label":39,"type":10,"description":40,"interventionNames":41},"Extracapsular hip fracture FENTANYL","Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for osteosinthesis of hip fracture.",[26],[43,49,53,57],{"type":44,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"PROCEDURE","PENG and LFCN peripheral nerve blocks with spinal anesthesia","At first, one needs to detect hyperechogenic iliopsoas notch and psoas tendon, between anterior inferior iliac spine and iliopubic eminence. Then needle needs to be inserted in-plane and 20mL of levobupivacaine 0.25% administered along the fascial plane. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Curvilinear probe will be used.\n\nFor spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3\u002F4 level using 25 G spinal needle.",[32,15],null,{"type":44,"name":50,"description":51,"armGroupLabels":52,"otherNames":48},"FN and LFCN peripheral nerve blocks with spinal anesthesia","At first, one needs to detect both femoral artery and vein medial to it. Then needle needs to be inserted in-plane and 15mL of levobupivacaine 0.5% need to be administered underneath fascia iliaca, lateral to femoral nerve. Additionally, after identification of sartorius muscle, 5mL of levobupivacaine 0.5% need to be administered in a space between sartorius and tensor fascia latae muscles, where lateral femoral cutaneous nerve can be identified as a hyperechoic structure. Single shot needle, with bevel up, will be visible all the time, in plane technique will be used. The spread of the local anesthetic will appear hypoechoic on ultrasound. Linear probe will be used.\n\nFor spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3\u002F4 level using 25 G spinal needle.",[28,9],{"type":44,"name":54,"description":55,"armGroupLabels":56,"otherNames":48},"FIC peripheral nerve block with spinal anesthesia","Suprainguinal approach will be performed. At first, one needs to detect anterior inferior iliac spine, sartorius and internal oblique muscles creating a bow-tie. Deep circumflex iliac artery will be seen between transversus abdominis and iliacus muscle. Then needle needs to be inserted in-plane and 40mL of levobupivacaine 0.25% administered along the fascial plane so that fascia separates from iliacus muscle. The needle is inserted from caudal to cranial, to achieve the widest possible spread of local anesthetic under the fascia, to the cranial side, as this reaches both lateral femoral cutaneous nerve and femoral nerve. The spread of anesthetic will appear hypoechoic on ultrasound. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3\u002F4 level using 25 G spinal needle.",[35,19],{"type":44,"name":58,"description":59,"armGroupLabels":60,"otherNames":48},"Fentanyl (IV) with spinal anesthesia","A total dose of 2 mcg\u002Fkg of fentanyl will be given to patients before positioning to spinal. For spinal anesthesia levobupivacaine will be placed in the subarachnoid space at lumbar vertebrae 3\u002F4 level using 25 G spinal needle.",[39,23],[62,66,69,71,73,75,77,79,81,83,85,88],{"name":63,"affiliation":64,"role":65},"Ana Saric Jadrijev, MD","Department of Anaesthesiology and Intensive Care, University Hospital of Split","PRINCIPAL_INVESTIGATOR",{"name":67,"affiliation":64,"role":68},"Ruben Kovac, MD","STUDY_CHAIR",{"name":70,"affiliation":64,"role":68},"Marija Kljucevic, MD",{"name":72,"affiliation":64,"role":68},"Petra Bajto, MD",{"name":74,"affiliation":64,"role":68},"Meri Mirceta, MD",{"name":76,"affiliation":64,"role":68},"Ana Maria Mitar, MD",{"name":78,"affiliation":64,"role":68},"Ana Bego, MD",{"name":80,"affiliation":64,"role":68},"Josipa Modric, MD",{"name":82,"affiliation":64,"role":68},"Nikola Delic, MD, PhD",{"name":84,"affiliation":64,"role":68},"Toni Kljakovic-Gaspic, MD, PhD",{"name":86,"affiliation":87,"role":68},"Nikola Kljucevic, MD, PhD","Department of Surgery, University Hospital of Split",{"name":89,"affiliation":87,"role":68},"Boris Luksic, MD, PhD",[91,95],{"name":63,"role":92,"phone":93,"phoneExt":48,"email":94},"CONTACT","385981788627","ana_saric@yahoo.com",{"name":76,"role":92,"phone":96,"phoneExt":48,"email":97},"385916026084","anamaria.mitar@gmail.com",[99],{"facility":5,"status":48,"city":100,"state":48,"zip":101,"country":102,"countryCode":103,"cosmosGeoPoint":104,"geoPoint":109,"contacts":48},"Split","21000","Croatia","HR",{"type":105,"coordinates":106},"Point",[107,108],16.43915,43.50891,{"lat":108,"lon":107},{"type":65,"investigatorFullName":111,"investigatorTitle":112,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"Ana Saric Jadrijev","MD, Anaesthesiology, Reanimatology and Intensive Medicine Specialist, Principal Investigator","100602937","phase-4-preoperative-use-of-peripheral-nerve-blocks-in-elderly-patients-with-hip-fractures-100602937",false,"NCT07130006","Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures","Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures: a Factorial Randomized Clinical Trial","Inclusion Criteria:\n\n* both sexes\n* 60 years old and older\n* diagnosed with a hip fracture resulting from low-energy trauma\n* scheduled surgery.\n\nExclusion Criteria:\n\n* polytraumatized patients\n* dementia and acute psychosis patients\n* patients for whom spinal anesthesia is contraindicated\n* patients with severe renal failure\n* patients for whom intravenous administration of tranexamic acid is contraindicated\n* patients with proven allergy and contraindications to dexamethasone, non-steroidal anti-rheumatic drugs, opioid analgesics, magnesium sulfate.","ALL","60 Years",{"count":123,"type":124},256,"ESTIMATED","INTERVENTIONAL",[127],"PHASE4","The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are:\n\n* which peripheral nerve block is the best regarding analgesia\n* which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia?\n* which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous?\n* which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy?\n* what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery?\n* what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution.\n\nAll respondents will, in addition to obligatory intraoperative monitoring,:\n\n* be thoroughly examined by anesthesiologists before surgery\n* be closely monitored after surgery, until their hospital discharge.",[130,131,132,133,134,135,136],"Fractures, Hip","Femoral Neck Fractures","Intertrochanteric Fractures","Subtrochanteric Fractures","Aged","Frail Older Adults","Elderly",[138,139,140,141,142,143,144,145,146,147],"elderly","ultrasound-guided","peripheral nerve blocks","intravenous fentanyl","spinal anaesthesia","EQ-5D-5L","visual analog scale","pain at rest","dynamic pain","hip fracture surgery","NOT_YET_RECRUITING","2025-08-11",{"date":151,"type":152},"2025-08-19","ACTUAL",{"date":154,"type":124},"2025-08-30",{"date":156,"type":124},"2026-03-31",{"name":5,"class":6},1]