[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573429":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":60,"collaborators":25,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Jessa Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"iPACK with Femoral Triangle Block (FTB)","ACTIVE_COMPARATOR","Patients undergoing an unillateral total kneearthroplasty will receive the anesthetic combination iPACK with FTB.",[13],"Procedure: Locoregional anesthesia",{"label":15,"type":10,"description":16,"interventionNames":17},"Surgical Local Infiltration Analgesia (LIA)","Patients undergoing an unillateral total kneearthroplasty will receive the surgical LIA.",[18],"Procedure: Local Anesthetic Ropivacaine",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Locoregional anesthesia","The FTB + iPACK group will receive 12 ml 0,5% ropivacaine for the FTB and 20 ml of ropivacaine 0.5% for the iPACK block under US guidance after spinal anesthesia",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Local Anesthetic Ropivacaine","The control group (LIA) will receive 120 ml 0.25% ropivacaine for surgical LIA placement.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Bjorn Stessel, MD, PhD","CONTACT","003211222107","bjorn.stessel@jessazh.be",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"Ina Callebaut, PhD","003211339848","ina.callebaut@jessazh.be",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Hasselt","Limburg","3500","Belgium","BE",{"type":49,"coordinates":50},"Point",[51,52],5.33781,50.93106,{"lat":52,"lon":51},[55,57,58],{"name":37,"role":33,"phone":56,"phoneExt":25,"email":39},"+33211339848",{"name":32,"role":33,"phone":35,"phoneExt":25,"email":25},{"name":32,"role":59,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Stessel Björn","MD, PhD","100573429","block-study-better-local-orthopedic-pain-control-after-knee-arthroplasty-100573429",false,"NCT06746168","BLOCK-study: Better Local Orthopedic Pain Control After Knee Arthroplasty","Infiltration of Local Anesthetics Between the Popliteal Artery and Capsule of the Knee (iPACK) With Femoral Triangle Block (TFB) Versus Surgical Local Infiltration Analgesia (LIA) in Unilateral Total Knee Arthroplasty (TKA): A Multicenter Double-blind, Prospective Randomized Controlled Study.","BLOCK","Inclusion Criteria:\n\n* ASA I-III\n* BMI 17-35 kg\u002Fm2\n* Patient is able to give informed consent\n* Patient is scheduled for TKA\n\nExclusion Criteria:\n\n* Refusal of patient\n* Inability to communicate due to language or neurologic barriers\n* Bilateral TKA or unilateral knee arthroplasty\n* Chronic opioid use (including partial opioid agonists) + chronic pain patients:\n* Use of atypical analgesics (gabapentin, pregabalin, …)\n* History of Sudeck atrophy\n* History of \\>3 chronic pain consultations\n* Contraindications for spinal anesthesia\n* Patient refusal\n* Local infection\n* Aberrant coagulation (according to the latest ESRA guidelines)\n* Severe spinal canal stenosis\n* Intracranial hypertension\n* History of neurological injury in the affected limb\n* Contraindications for local anesthetics\n* Allergy for local anesthetics\n* Absolute contraindications for NSAIDs or paracetamol\n* Proven allergy for NSAID's (including ASA syndrome) or paracetamol\n* Severe renal function impairment (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2)\n* Active or recent (\\\u003C6 months) history of gastric ulcera\u002Fperforations\u002Fbleeding\n* Crohn disease or colitis ulcerosa\n* Liver function impairment or severe renal function impairment (eGFR \\\u003C30 ml\u002Fmin\u002F1.73 m2)\n* Pregnancy or breast-feeding","ALL","18 Years","85 Years",{"count":76,"type":77},210,"ESTIMATED","INTERVENTIONAL",[80],"NA","The goal of this study is to compare the anesthetic combination iPACK with femoral triangle block versus surgical LIA for unilateral TKA. We hypothesize that an iPACK block with femoral triangle block is non-inferior to surgical LIA. Furthermore, due to visualization of the relevant neural and vascular structures, the risk of accidental popliteal block, nerve damage or LAST with (a blindly performed) LIA could theoretically be reduced.",[83],"Knee Arthroplasty, Total",[85,86,87,88],"iPACK","Femoral Triangle Block","Local infiltration analgesia","knee arthoplasty","2025-02-18",{"date":91,"type":92},"2025-02-20","ACTUAL",{"date":94,"type":92},"2025-01-09",{"date":96,"type":77},"2027-11-30",{"name":5,"class":6},1]