Actively Recruiting

Phase Not Applicable
Age: 18Years - 85Years
All Genders
ID06773780

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

Led by Medipol University · Updated on 2025-12-02

60

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Aortic Stenosis (AS) is a common heart valve condition affecting mostly older adults, especially those over 75. Surgical replacement is the usual treatment, but many high-risk patients cannot undergo surgery due to age or other health problems. Transcatheter Aortic Valve Implantation (TAVI) offers a less invasive alternative, improving outcomes for those who cannot have surgery. This study compares different types of anesthesia used during TAVI to find the best approach for patient comfort and safety. The study compares three anesthesia methods during TAVI: local infiltration anesthesia, Pericapsular Nerve Group (PENG) block, and Fascia Iliaca Block (FIB). Local infiltration involves injecting anesthetic around the puncture sites. The PENG block uses ultrasound to target specific nerves near the hip without causing muscle weakness. The FIB blocks multiple nerves around the hip area using ultrasound guidance. Each method uses 30 ml of 0.25% bupivacaine, applied with precise techniques under sterile conditions. Participants will undergo TAVI with one of the three anesthesia methods. Researchers will monitor sedation needs during the procedure and evaluate pain levels, opioid use, motor block presence, and side effects like nausea or vomiting after surgery. Sedation frequency and medication amounts during TAVI are primary outcomes. The study aims to determine which anesthesia provides the best pain relief and safety for patients undergoing TAVI, with monitoring continuing through the first 24 hours after surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled for Transcatheter Aortic Valve Implantation (TAVI)
  • Aged between 18 and 85 years
  • American Society of Anesthesiology (ASA) physical status II-IV
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Day of the procedure

Participants receive one of three types of anesthesia blocks (PENG block, Fascia Iliaca Block, or local infiltration) during the Transcatheter Aortic Valve Implantation (TAVI) procedure to manage pain and sedation requirements.

1 procedure visit (in-person)

Post-operative Follow-up

Duration - First 24 hours after the operation

Participants are monitored for postoperative pain levels, opioid consumption, and side effects such as nausea and vomiting during the first 24 hours after the procedure.

Approximately 1 day of monitoring with assessments

Trial Site Locations

Total: 1 location

1

Medipol University

Istanbul, Turkey (Türkiye)

Actively Recruiting

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Research Team

B

Burak Ömür

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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Published Research Related To This Trial