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

December 1, 2025 updated by: Burak Omur, Medipol University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Aortic Stenosis (AS) is the most common valvular pathology, affecting 2% to 4% of individuals over the age of 75. Surgical Aortic Valve Replacement (SAVR) has long been considered the first-line recommendation for AS treatment. However, due to advanced age and the increasing prevalence of severe comorbidities, more than one-third of high-risk and severely symptomatic AS patients are deemed physiologically unsuitable for major surgical interventions.

This situation has led to the development and implementation of Transcatheter Aortic Valve Implantation (TAVI) as an alternative intervention for high-risk patients and those deemed unsuitable for surgery. This shift towards minimally invasive procedures has resulted in revolutionary improvements in clinical outcomes, particularly for AS patients previously considered ineligible for surgery.

Advances in patient selection criteria and operative techniques have made significant contributions to the success of TAVI. Both retrograde and anterograde operative approaches can be employed during the TAVI procedure. While the transfemoral approach remains the most commonly used technique, alternative methods such as transapical, transaxillary, transcarotid, and transaortic approaches are also available. The choice of operative technique largely depends on patient-specific anatomical features and existing comorbidities.

Pericapsular Nerve Group Block (PENG Block) The increasing use of ultrasound (US) in anesthetic practice has facilitated the frequent application of US-guided nerve blocks. The Pericapsular Nerve Group Block (PENG Block) is a novel fascial block first described by Arango et al. In this technique, local anesthetic is injected between the pubic ramus and the psoas tendon, targeting the femoral and accessory obturator nerves to provide effective analgesia for the anterior hip region.

The PENG block has the advantage of not causing motor block. Its superficial applicability makes it a safe and effective method. Radiological and cadaver studies have shown that high-volume local anesthetic injections can also block the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves, enabling total hip analgesia.

Fascia Iliaca Block (FIB) The Fascia Iliaca Block (FIB) is an effective fascial block technique capable of simultaneously affecting multiple nerves. This block aims to anesthetize the lateral femoral cutaneous, obturator, and femoral nerves, providing broad analgesic coverage. FIB is performed away from critical inguinal neurovascular structures, enhancing its reliability. It is particularly preferred in pain management scenarios, such as acute hip fractures, and is considered a safe option for these clinical situations.

Aim of the Study This prospective, randomized study aims to compare the sedation requirements during the procedure and the postoperative analgesia management in TAVI patients undergoing PENG block, FIB, or local infiltration anesthesia. The primary objective is to evaluate the sedation needs of patients during the procedure. The secondary objectives include comparing postoperative pain scores (Numerical Rating Scale - NRS), the presence of quadriceps motor block (paretic or paralytic knee extension), opioid consumption, and opioid-related side effects (e.g., allergic reactions, nausea, vomiting).

This study aims to analyze the efficacy and safety of different analgesia methods, contributing to the identification of optimal strategies to enhance patient comfort and safety during TAVI procedures.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Local infiltration
Under sterile conditions, 30 ml of 0.25% bupivacaine will be applied to the targeted infiltration area.
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.
Active Comparator: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated.
Time Frame: during the procedure
The amounts of anesthetic and opioid drugs used during the procedure will be compared.
during the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The aim of this study is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression) of the patients between the groups.
Time Frame: first 24 hours after the operation
It will be evaluated whether there are any opioid-related side effects.
first 24 hours after the operation
the aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.
Time Frame: first 24 hours after the operation
The NRS is an 11-point scale. Zero means 'no pain', 10 means 'the most severe pain imaginable'. NRS scores at rest and during mobilization are evaluated and recorded in the postoperative recovery unit at 3, 6, 12, 18 and 24 hours. If the NRS score is ≥ 4, 1 mg kg-1 IV tramadol is administered as a rescue analgesic.
first 24 hours after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

January 12, 2025

First Posted (Actual)

January 14, 2025

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

December 1, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAVİ PENG VS FİB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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