[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100635121":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":58,"studyPopulation":48,"armGroups":59,"interventions":77,"overallOfficials":48,"centralContacts":48,"locations":48,"responsibleParty":89,"collaborators":48,"id":93,"slug":48,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":94,"sex":100,"minAge":101,"maxAge":48,"enrollmentInfo":102,"targetDuration":48,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":120,"whyStopped":48,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":48},{"fullName":5,"class":6},"National and Kapodistrian University of Athens","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of tourniquet-induced hypertension","Tourniquet-induced hypertension defined as an increase in systolic blood pressure greater than 30% from baseline values during tourniquet application.","From tourniquet inflation to 90 minutes intraoperatively",[14,17,21,24,28,31,35,38,42,45],{"measure":15,"description":16,"timeFrame":12},"Heart rate","Changes in heart rate during tourniquet application at predefined time points.",{"measure":18,"description":19,"timeFrame":20},"Intraoperative esmolol consumption","Total dose of esmolol administered for treatment of hypertension during surgery.","Intraoperative period",{"measure":22,"description":23,"timeFrame":20},"Intraoperative remifentanil consumption","Total remifentanil dose administered during surgery.",{"measure":25,"description":26,"timeFrame":27},"Postoperative pain score (VAS)","Pain intensity measured using Visual Analog Scale (0-10) in the recovery unit.","0-60 minutes postoperative",{"measure":29,"description":30,"timeFrame":27},"Morphine consumption in recovery unit","Total morphine dose required for rescue analgesia in the postoperative recovery period.",{"measure":32,"description":33,"timeFrame":34},"Femoral nerve block spread","Incidence of unintended femoral nerve blockade assessed by quadriceps strength and sensory testing.","Immediate postoperative period",{"measure":36,"description":37,"timeFrame":34},"Saphenous nerve block spread","Incidence of sensory block in saphenous nerve distribution assessed by pinprick test.",{"measure":39,"description":40,"timeFrame":41},"Imaging time","Time from ultrasound probe placement to optimal image acquisition.","During FAB block procedure",{"measure":43,"description":44,"timeFrame":41},"Needling time","Time from needle insertion to completion of local anesthetic or saline injection.",{"measure":46,"description":47,"timeFrame":41},"Total block performance time","Total time required for ultrasound imaging, needle placement and completion of local anesthetic or saline injection.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":55},"DOUBLE",[56,57],"PARTICIPANT","INVESTIGATOR","Tourniquet application during lower limb orthopedic surgery is associated with significant hemodynamic responses, including pain and tourniquet-induced hypertension (TH), which may increase perioperative cardiovascular risk. Femoral artery block (FAB) is a novel ultrasound-guided regional anesthesia technique targeting the perivascular sympathetic plexus surrounding the femoral artery to attenuate these responses.\n\nPrevious studies have described FAB using a short-axis in-plane ultrasound approach. This study proposes a novel long-axis in-plane ultrasound technique, hypothesizing that longitudinal visualization of the femoral artery may improve anatomical alignment with perivascular sympathetic structures, resulting in more effective sympathetic blockade, improved safety, and enhanced clinical efficacy.\n\nThis is a prospective, randomized, double-blind controlled trial including adult patients (ASA I-III) scheduled for below-the-knee fracture surgery requiring tourniquet application for at least 45 minutes. After informed consent and baseline assessment, patients will be randomized into three groups: (1) short-axis FAB with ropivacaine, (2) long-axis FAB with ropivacaine, and (3) control group receiving normal saline injection.\n\nAll patients will receive standardized anesthetic management including sciatic nerve block at the popliteal level and total intravenous anesthesia using propofol and remifentanil via Target-Controlled Infusion (TCI) under BIS monitoring. Hemodynamic variables (blood pressure and heart rate) will be recorded at predefined intraoperative and postoperative time points. Tourniquet-induced hypertension will be defined as a \\>30% increase in systolic blood pressure from baseline.\n\nSecondary outcomes include intraoperative opioid and vasopressor requirements, incidence of femoral and saphenous nerve spread, procedural performance metrics (imaging and needling time), postoperative pain scores (VAS), and opioid consumption in the recovery unit.\n\nData will be analyzed using repeated-measures and comparative statistical models to evaluate differences between groups over time and between interventions.",[60,66,71],{"label":61,"type":62,"description":63,"interventionNames":64},"Short-axis femoral artery block","EXPERIMENTAL","Ultrasound-guided femoral artery block using short-axis in-plane technique with 10 mL ropivacaine 0.5%.",[65],"Procedure: Femoral artery block - short-axis",{"label":67,"type":62,"description":68,"interventionNames":69},"Long-axis femoral artery block","Ultrasound-guided femoral artery block using long-axis in-plane technique with 10 mL ropivacaine 0.5%.",[70],"Procedure: Femoral artery block - long-axis",{"label":72,"type":73,"description":74,"interventionNames":75},"Saline control injection","PLACEBO_COMPARATOR","Ultrasound-guided femoral artery injection using in-plane technique with 10 mL 0.9% normal saline.",[76],"Other: Normal saline injection (control)",[78,82,85],{"type":79,"name":80,"description":63,"armGroupLabels":81,"otherNames":48},"PROCEDURE","Femoral artery block - short-axis",[61],{"type":79,"name":83,"description":68,"armGroupLabels":84,"otherNames":48},"Femoral artery block - long-axis",[67],{"type":6,"name":86,"description":87,"armGroupLabels":88,"otherNames":48},"Normal saline injection (control)","Ultrasound-guided femoral artery injection using 10 mL 0.9% normal saline.",[72],{"type":90,"investigatorFullName":91,"investigatorTitle":92,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Banasiou Lamprini","Principal Investigator","100635121",false,"NCT07548567","A Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery","Turning the Probe, Changing the View: A Novel Long Axis Approach to the Femoral Artery Block (FAB) for Managing Tourniquet Pain and Hypertension in Below-the-Knee Fracture Surgery: A Prospective, Randomized, Double-Blind Controlled Trial","FAB","Inclusion Criteria:\n\n* Age \\>18 years\n* Physical status ASA I-III\n* Fluent in Greek or English\n* Scheduled surgery: below-knee fractures\n* Tourniquet duration ≥45 minutes\n\nExclusion Criteria:\n\n* Refusal to participate\n* Local inflammation at block site\n* Known allergy to study drugs\n* Morbid obesity (BMI \\>40)\n* Communication inability\n* Systemic neurological disease affecting peripheral nerves\n* Chronic pain therapy\n* Diabetic neuropathy\n* Uncontrolled hypertension","ALL","18 Years",{"count":103,"type":104},84,"ESTIMATED","INTERVENTIONAL",[107],"NA","This is a prospective, randomized, double-blind controlled trial evaluating an ultrasound-guided femoral artery block (FAB) using a long-axis in-plane approach compared with a short-axis approach and a control group.\n\nThe study will include adult patients (ASA I-III) undergoing below-the-knee fracture surgery with tourniquet application. All patients will receive standardized anesthesia including sciatic nerve block and total intravenous anesthesia.\n\nParticipants will be randomized into three groups: short-axis FAB, long-axis FAB, or control (saline injection). The primary aim is to assess the effectiveness of the long-axis FAB in reducing tourniquet-induced hypertension. Secondary outcomes include hemodynamic stability, analgesic requirements, pain scores, block characteristics, and procedural performance metrics.",[110],"Tourniquet Hypertension",[112,113,114,115,116,117,118,119],"FAB block","Tourniquet-induced hypertension","Tourniquet pain","Below-knee fracture surgery","Sympathetic blockade","intraoperative hypertension","sciatic nerve block","randomized controlled trial","NOT_YET_RECRUITING","2026-04-29",{"date":123,"type":124},"2026-04-30","ACTUAL",{"date":126,"type":104},"2026-05",{"date":128,"type":104},"2028-02",{"name":5,"class":6}]