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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients scheduled for TAVİ
- •aged between 18 and 85 years,
- •American Society of Anesthesiology (ASA) physical status II-IV
排除标准
- •xclusion 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
研究组 & 干预措施
Local infiltration
Under sterile conditions, 30 ml of 0.25% bupivacaine will be applied to the targeted infiltration area.
干预措施: local infiltration (Drug)
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.
干预措施: PENG (Drug)
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.
干预措施: FİB (Drug)
结局指标
主要结局
The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated.
时间窗: during the procedure
The amounts of anesthetic and opioid drugs used during the procedure will be compared.
次要结局
- the aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.(first 24 hours after the operation)
- The aim of this study is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression) of the patients between the groups.(first 24 hours after the operation)
研究者
Burak Omur
Assistant Professor
Medipol University
