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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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. Patient 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. The 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. This 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.

Who May Be Eligible (Plain English)

Who May Qualify: - Patients scheduled for TAVİ - aged between 18 and 85 years, - American Society of Anesthesiology (ASA) physical status II-IV Who Should NOT Join This Trial: - History of bleeding diathesis. - Use of anticoagulant therapy. - History of chronic pain prior to surgery. - Multiple trauma. - Conditions where pain assessment cannot be performed (e.g., dementia). - Patients operated under spinal or epidural anesthesia. - Presence of infection in the region where the block will be applied. - Refusal to consent to the procedure Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Patients scheduled for TAVİ * aged between 18 and 85 years, * American Society of Anesthesiology (ASA) physical status II-IV Exclusion Criteria: * History of bleeding diathesis. * Use of anticoagulant therapy. * History of chronic pain prior to surgery. * Multiple trauma. * Conditions where pain assessment cannot be performed (e.g., dementia). * Patients operated under spinal or epidural anesthesia. * Presence of infection in the region where the block will be applied. * Refusal to consent to the procedure

Treatments Being Tested

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.

DRUG

PENG

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.

DRUG

FİB

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.

Locations (1)

Medipol University
Istanbul, Turkey (Türkiye)