[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100530796":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":28,"studyPopulation":17,"armGroups":29,"interventions":46,"overallOfficials":17,"centralContacts":17,"locations":59,"responsibleParty":79,"collaborators":17,"id":83,"slug":17,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":17,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":17,"enrollmentInfo":91,"targetDuration":17,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":105,"whyStopped":17,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Uludag University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Success rates on the first attempt.","The primary outcome is to compare the success rates on the first attempt.","Preoperatively",[14],{"measure":15,"description":16,"timeFrame":12},"Number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction","The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications (radicular pain, postdural puncture headache, hematoma, paresthesia) and patient satisfaction.\n\nNeedle redirection was defined as any change in needle insertion trajectory not involving complete withdrawal of the needle from the patient's skin.\n\nProcedure time was defined as the total duration from the placement of the probe on the skin to the completion of skin marking and from the insertion of the needle into the skin to the observation of cerebrospinal fluid (CSF) outflow using the designated technique.\n\nPatient satisfaction will be evaluated on a scale of 1 to 5 (1:extremely unsatisfied; 5:extremely satisfied).",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","PARALLEL","PREVENTION",{"masking":23,"maskingDescription":17,"whoMasked":24},"TRIPLE",[25,26,27],"PARTICIPANT","CARE_PROVIDER","OUTCOMES_ASSESSOR","Patients included in the study will be those undergoing lower extremity orthopedic surgery, with a body mass index (BMI) 30 kg\u002Fm² and above, and classified as American Society of Anesthesiologists (ASA) class I-III. Patients will be randomized into 3 groups. In the Conventional Landmark group, spinal anesthesia will be administered using the conventional technique. In the Ultrasound-Assisted group, the spinal space will be marked with ultrasound before proceeding. For the Real-Time Ultrasound-Guided group, the spinal space and the advancement of the needle for the injection will be visualized simultaneously with ultrasound during the application of spinal anesthesia. The primary outcome is to compare the success rates on the first attempt. The secondary outcomes are to compare the number of skin punctures, needle redirections, procedure times, complications, and patient satisfaction",[30,36,41],{"label":31,"type":32,"description":33,"interventionNames":34},"Conventional Landmark Group","ACTIVE_COMPARATOR","The investigator will perform spinal anesthesia using the conventional landmark technique.",[35],"Procedure: Conventional Landmark Technique",{"label":37,"type":32,"description":38,"interventionNames":39},"USAS Group","The investigator will perform spinal anesthesia using ultrasound-assisted technique.",[40],"Procedure: Ultrasound Assisted Technique",{"label":42,"type":32,"description":43,"interventionNames":44},"US-RTG Group","The investigator will perform spinal anesthesia using real-time ultrasound-guided technique.",[45],"Procedure: Real-Time Ultrasound Guided Technique",[47,51,55],{"type":48,"name":49,"description":33,"armGroupLabels":50,"otherNames":17},"PROCEDURE","Conventional Landmark Technique",[31],{"type":48,"name":52,"description":53,"armGroupLabels":54,"otherNames":17},"Ultrasound Assisted Technique","The investigator will perform spinal anesthesia using the ultrasound assisted technique.",[37],{"type":48,"name":56,"description":57,"armGroupLabels":58,"otherNames":17},"Real-Time Ultrasound Guided Technique","The investigator will perform spinal anesthesia using the real-time ultrasound-guided technique.",[42],[60],{"facility":61,"status":17,"city":62,"state":17,"zip":63,"country":64,"countryCode":17,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Bursa Uludag University Faculty of Medicine","Bursa","16059","Turkey (Türkiye)",{"type":66,"coordinates":67},"Point",[68,69],29.06013,40.19559,{"lat":69,"lon":68},[72,77],{"name":73,"role":74,"phone":75,"phoneExt":17,"email":76},"SELCAN AKESEN","CONTACT","+902242953274","selcanakesen@uludag.edu.tr",{"name":78,"role":74,"phone":17,"phoneExt":17,"email":17},"Kübra Cebeci",{"type":80,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":17,"oldOrganization":17},"PRINCIPAL_INVESTIGATOR","Selcan Akesen","Associate Professor","100530796",false,"NCT06191445","Comparison of the Efficacy of Conventional Landmark, Ultrasound-Assisted, and Real-Time Ultrasound-Guided Techniques in Spinal Anesthesia for Obese Patients","Does the Use of Ultrasound Increase Spinal Anesthesia Success for Obese Patients?: Evaluation of the Success of Spinal Anesthesia Administered with Real-Time Ultrasound-Guided, Ultrasound-Assisted and Conventional Landmark Techniques","Inclusion Criteria:\n\n* 18 years and older\n* Patients who will undergo lower extremity orthopedic surgery\n* ASA I-II-III patients\n* BMI 30 kg\u002Fm² and above\n\nExclusion Criteria:\n\n* BMI \\\u003C 30 kg\u002Fm²\n* ASA IV-V patients\n* Severe cardiovascular disease\n* Patients with a known or suspected allergy to local anesthetics\n* Contraindications of spinal anesthesia (eg, coagulopathy, puncture site infection)","ALL","18 Years",{"count":92,"type":93},126,"ESTIMATED","INTERVENTIONAL",[96],"NA","Spinal anesthesia is frequently administered using the conventional landmark technique. Ultrasound is a non-invasive and safe approach. Neuroaxial anesthesia procedures can be conducted using two different ultrasound techniques; Real-Time Ultrasound Guided (USRTG) and Ultrasound-Assisted (USAS). The primary objective of this study is to compare the successes of spinal anesthesia applications using USRTG, USAS, and conventional landmark techniques on the first attempt in obese patients undergoing orthopedic surgery.",[99,100],"Spinal Anesthesia","Ultrasound",[102,99,103,104],"Anesthesia","Obesity","Ultrasonography","NOT_YET_RECRUITING","2024-10-11",{"date":108,"type":109},"2024-10-16","ACTUAL",{"date":111,"type":93},"2024-11-15",{"date":113,"type":93},"2025-08-01",{"name":5,"class":6},1]