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临床试验/NCT05904912
NCT05904912已完成不适用

Evaluation of the Effect of Ultrasound-guided PENG Block on Postoperative Analgesia Management in Patients Undergoing Transcatheter Aortic Valve Implantation: A Randomized, Prospective Study

Medipol University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年6月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
The need for fentanyl during the procedure

研究概览

简要总结

Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.

详细描述

Aortic valve stenosis (AS) is the most common valve pathology, affecting 2% to 4% of patients over the age of 75. Surgical aortic valve replacement (SAVR) has been accepted as a class I recommendation for the treatment of AS for decades. However, given that advanced age, frailty, and significant comorbidities are increasingly common in affected patients; More than one-third of high-risk and severely symptomatic AS patients are physiologically unsuitable for major surgery. This is the development and implementation of TAVI, an appropriate intervention for high-risk patients and those deemed unsuitable for surgery. With a shift in the clinical paradigm towards minimally invasive procedures, the development of TAVI has revolutionized clinical outcomes in AS, particularly in those once considered inoperable.

Selective candidate criteria and advances in operative techniques within TAVI are major contributors to successful outcomes. Basically, there are both retrograde and anterograde operative approaches that can be adopted within a TAVI procedure. While the transfemoral approach remains the most widely used, others include the transapical, transaxillary, transported, and transaortic pathways. The choice of technique adopted is greatly influenced by patient-related factors such as anatomical considerations and comorbidities present.

Because of the increasing use of ultrasound (US) in anesthesia practice, nerve blocks with US guidance are widely used. Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.

This prospective, randomized study, it was aimed to evaluate the efficacy of the PENG block for the management of analgesia during and after the procedure in patients undergoing TAVI. Our primary aim is to evaluate pain scores (Numerical Rating Scale-NRS), our secondary aim is to evaluate the amount of additional sedation intraoperatively, the degree of quadriceps motor block (paresis or paralysis in knee extension), and opioid-related side effects (allergic reaction, nausea, vomiting, etc.).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

盲法说明

Outcomes Assessor and participant will be blinded to the study

入排标准

年龄范围
20 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with ASA classification I-III,
  • Aged 20-80 years
  • Who will be scheduled for TAVI.

排除标准

  • Patients who have a history of bleeding diathesis,
  • Take anticoagulant therapy,
  • History of chronic pain before surgery,
  • Multiple trauma,
  • Who cannot assess their pain (dementia),
  • Who have been operated under spinal or epidural anesthesia,
  • Who have an infection in the area and do not accept the procedure

研究组 & 干预措施

Group PENG = PENG block

Active Comparator

PENG block will be performed

干预措施: Postoperative analgesia management (Drug)

Group PENG = PENG block

Active Comparator

PENG block will be performed

干预措施: PENG-Bupivacaine (Drug)

Group C = Control group

Other

Local infiltration will be applied.

干预措施: Postoperative analgesia management (Drug)

Group C = Control group

Other

Local infiltration will be applied.

干预措施: Local infiltration-Bupivacaine (Drug)

结局指标

主要结局

The need for fentanyl during the procedure

时间窗: Intraoperative period

Intraoperative additional fentanyl need and dosage will be recorded

次要结局

  • Quadriceps muscle strength(Postoperative 24 hours period)
  • The use of rescue analgesia(Postoperative 24 hours period])
  • Pain scores (Numerical Rating Scale-NRS)(Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours)

研究者

发起方
Medipol University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahadir Ciftci

Primary researcher

Medipol University

研究点 (1)

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