NCT06773780 Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management
| NCT ID | NCT06773780 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medipol University |
| Condition | Aortic Valve Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-01-10 |
| Primary Completion | 2026-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-01-10 with a primary completion date of 2026-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06773780 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06773780 currently recruiting?
Yes, NCT06773780 is actively recruiting participants. Contact the research team at bomur@medipol.edu.tr for enrollment information.
Where is the NCT06773780 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06773780 clinical trial?
NCT06773780 is sponsored by Medipol University. The trial plans to enroll 60 participants.