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Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management

Key facts

Who runs it
Medipol University
Where
Istanbul, TürkiyeSee the site
Trial code
Status
Recruiting
People taking part
60 people, planned
Started
10 Jan 2025
Expected to end
1 Dec 2026
Type of study
Interventional, 3 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • local infiltration
  • PENG
  • FİB
Record updated
27 July 2026

Who can take part

Age
18 years to 85 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

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Who can take part

  • Patients scheduled for TAVİ
  • aged between 18 and 85 years,
  • American Society of Anesthesiology (ASA) physical status II-IV

Who cannot take part

  • Use of anticoagulant therapy
  • History of chronic pain prior to surgery
  • History of bleeding diathesis
  • Conditions where pain assessment cannot be performed (e.g., dementia)
  • Presence of infection in the region where the block will be applied
  • Multiple trauma
  • Patients operated under spinal or epidural anesthesia
  • Refusal to consent to the procedure

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 85 years old?

Where in Türkiye

  • Medipol UniversityIstanbul, TürkiyeContact: Burak ÖmürTaking people

About the trial

What the trial wants to find out

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.

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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.

The 3 groups in the trial

  • Local infiltrationExisting treatment, for comparison

    Under sterile conditions, 30 ml of 0.25% bupivacaine will be applied to the targeted infiltration area.

  • PENGExisting treatment, for comparison

    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.

  • FİBExisting treatment, for comparison

    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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
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
Fit questions
Built from NCT06773780, who can take part
Record updated
27 July 2026