Burden of valvular heart diseases: a population-based study.
Vuyisile T Nkomo, Julius M Gardin, Thomas N Skelton...
https://pubmed.ncbi.nlm.nih.gov/16980116Actively Recruiting
Led by Medipol University · Updated on 2025-12-02
60
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
Medipol University
Istanbul, Turkey (Türkiye)
Actively Recruiting
B
Burak Ömür
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
3
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