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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorMedipol University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for TAVİ

aged between 18 and 85 years,

American Society of Anesthesiology (ASA) physical status II-IV

Disqualifiers

History of bleeding diathesis.

Use of anticoagulant therapy.

History of chronic pain prior to surgery.

Multiple trauma.

Trial design

Design model

Parallel

Treatments tested in this trial

  • local infiltration

    Drug

    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.

  • PENG

    Drug

    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.

  • FİB

    Drug

    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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Local infiltrationActive comparator 1 intervention
Group B: PENGActive comparator 1 intervention
Group C: FİBActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated.

The amounts of anesthetic and opioid drugs used during the procedure will be compared.

Time frame
during the procedure

Secondary outcomes

1

the aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.

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.

Time frame
first 24 hours after the operation
2

The aim of this study is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression) of the patients between the groups.

It will be evaluated whether there are any opioid-related side effects.

Time frame
first 24 hours after the operation

Other outcomes

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