[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100575553":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":37,"locations":43,"responsibleParty":57,"collaborators":30,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":30,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":30,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":30,"overallStatus":45,"whyStopped":30,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Medipol University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Local infiltration","ACTIVE_COMPARATOR","Under sterile conditions, 30 ml of 0.25% bupivacaine will be applied to the targeted infiltration area.",[13],"Drug: local infiltration",{"label":15,"type":10,"description":16,"interventionNames":17},"PENG","For the PENG block, the patient is placed in the supine position, and a sterile-covered convex ultrasound probe is positioned transversely over the anterior inferior iliac spine. After identifying the femoral artery, iliopubic eminence, and psoas muscle, the needle is advanced in-plane between the pubic ramus and psoas tendon, and 30 mL of 0.25% bupivacaine is injected.",[18],"Drug: PENG",{"label":20,"type":10,"description":21,"interventionNames":22},"FİB","For the FIB, with the patient's legs slightly externally rotated, a high-frequency ultrasound probe is placed along the inguinal ligament. The needle is advanced beneath the fascia iliaca, and 30 mL of 0.25% bupivacaine is injected under ultrasound guidance.",[23],"Drug: FİB",[25,31,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","local infiltration","The block procedure will be performed before the surgical procedure, following the induction of sedoanalgesia. Under sterile conditions, 30 mL of 0.25% bupivacaine will be administered to the targeted infiltration area. The local anesthetic will be specifically applied around the arterial and venous puncture sites.",[9],null,{"type":26,"name":15,"description":32,"armGroupLabels":33,"otherNames":30},"With the patient in the supine position, a convex ultrasound (US) probe (4-8 MHz, Vivid Q) will be covered with a sterile sheath. An 80-mm block needle (Braun 360°) will be used. The probe will be placed transversely over the anterior inferior iliac spine. Subsequently, the probe will be rotated 45 degrees to visualize the pubic ramus. Once the femoral artery, iliopubic eminence, and psoas muscle are identified under ultrasound guidance, the needle will be advanced using an in-plane technique and positioned between the pubic ramus and the psoas tendon. After confirming the block site with 5 mL of saline, 30 mL of 0.25% bupivacaine will be injected as the local anesthetic.",[15],{"type":26,"name":20,"description":35,"armGroupLabels":36,"otherNames":30},"The patient's legs will be positioned slightly externally rotated. A high-frequency ultrasound probe will be placed transversely along the inguinal ligament. Under ultrasound guidance, the femoral artery, iliopsoas muscle, and fascia iliaca will be identified. The needle will be advanced parallel to the ultrasound probe using the in-plane technique and positioned beneath the fascia iliaca. After confirming negative aspiration, 30 mL of 0.25% bupivacaine will be injected, and the spread of the solution beneath the fascia iliaca will be verified using ultrasound.",[20],[38],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":42},"Burak Ömür","CONTACT","+905056215056","bomur@medipol.edu.tr",[44],{"facility":5,"status":45,"city":46,"state":30,"zip":30,"country":47,"countryCode":30,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Istanbul","Turkey (Türkiye)",{"type":49,"coordinates":50},"Point",[51,52],28.94966,41.01384,{"lat":52,"lon":51},[55],{"name":39,"role":40,"phone":41,"phoneExt":30,"email":56},"burakomur@outlook.com",{"type":58,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"PRINCIPAL_INVESTIGATOR","Burak Omur","Assistant Professor","100575553","transcatheter-aortic-valve-implantation-comparison-of-the-effects-of-ultrasound-guided-pericapsular-nerve-group-block-and-fascia-iliaca-block-on-postoperative-analgesia-management-100575553",false,"NCT06773780","Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management","Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management - A Randomized, Prospective Study","Inclusion Criteria:\n\n* Patients scheduled for TAVİ\n* aged between 18 and 85 years,\n* American Society of Anesthesiology (ASA) physical status II-IV\n\nExclusion Criteria:\n\n* History of bleeding diathesis.\n* Use of anticoagulant therapy.\n* History of chronic pain prior to surgery.\n* Multiple trauma.\n* Conditions where pain assessment cannot be performed (e.g., dementia).\n* Patients operated under spinal or epidural anesthesia.\n* Presence of infection in the region where the block will be applied.\n* Refusal to consent to the procedure","ALL","18 Years","85 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures.\n\nPatient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available.\n\nThe Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves.\n\nThis study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.",[79,80,81,82],"Aortic Valve Stenosis","Transcatheter Aortic Valve Implantation","Pericapsular Nerve Group Block","Fascia Iliaca Block","2025-12-01",{"date":85,"type":86},"2025-12-02","ACTUAL",{"date":88,"type":86},"2025-01-10",{"date":90,"type":73},"2026-12-01",{"name":5,"class":6},1]