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Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty (PENG-LFCN-EEG)

2026年11月2日 更新者:Kocaeli City Hospital

Effects of Combined Pericapsular Nerve Group (PENG) and Lateral Femoral Cutaneous Nerve (LFCN) Blocks on Anaesthetic Requirements and Electroencephalographic Depth of Anaesthesia During Total Hip Arthroplasty: A Randomized Controlled Trial

This prospective, randomized controlled trial aims to evaluate the effects of combined pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks on intraoperative anaesthetic consumption and electroencephalographic (EEG)-derived anaesthetic depth in patients undergoing elective total hip arthroplasty.

A total of 50 adult patients will be randomly allocated to two groups: combined PENG and LFCN blocks followed by general anaesthesia, or general anaesthesia alone. Anaesthetic depth will be monitored using the SedLine EEG monitoring system.

The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include remifentanil consumption, EEG-derived parameters including Patient State Index (PSI) and suppression ratio, haemodynamic variables, and recovery characteristics.

The study aims to determine whether combined regional blocks reduce anaesthetic requirements while maintaining adequate EEG-guided anaesthetic depth.

研究概览

详细说明

Total hip arthroplasty is frequently associated with significant nociceptive stimulation during surgery. Regional anaesthesia techniques, including the pericapsular nerve group (PENG) block and lateral femoral cutaneous nerve (LFCN) block, may reduce intraoperative nociceptive input and consequently decrease anaesthetic and opioid requirements.

This prospective, randomized controlled trial will include 50 patients aged 18-65 years with American Society of Anesthesiologists (ASA) physical status I-II who are scheduled for elective total hip arthroplasty.

Patients will be randomly assigned in a 1:1 ratio to either an intervention group receiving combined ultrasound-guided PENG and LFCN blocks before general anaesthesia or a control group receiving general anaesthesia without preoperative regional blocks.

General anaesthesia will be administered using a standardized EEG-guided protocol. During induction, propofol will be titrated to achieve a target Patient State Index (PSI) of 25-50, as monitored by the SedLine system. Following tracheal intubation, anaesthesia will be maintained with sevoflurane, with continuous EEG monitoring to maintain the target PSI range.

The primary outcome will be intraoperative sevoflurane consumption. Secondary outcomes will include total remifentanil consumption, EEG-derived anaesthetic depth parameters, suppression ratio measurements, the occurrence and duration of burst suppression, intraoperative haemodynamic variables, and postoperative recovery characteristics.

By comparing anaesthetic consumption and EEG-derived parameters between the two groups, this study aims to evaluate the effects of combined PENG and LFCN blocks on intraoperative anaesthetic requirements and EEG-guided anaesthetic depth during total hip arthroplasty.

研究类型

介入性

注册 (估计的)

50

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:AYSE SENCAN, M.D Anaesthesiology Specialist
  • 电话号码:+905078313235
  • 邮箱:draysesencan@gmail.com

学习地点

    • Kocaeli
      • Köseköy、Kocaeli、土耳其(türkiye)、41100
        • Kocaeli City Hospital
        • 接触:
        • 接触:
          • Ayse Zeynep Turan Civraz, Associated Professor
          • 电话号码:+905054695850
          • 邮箱:ayse.zeynep@gmail.com

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patients aged 18-65 years
  • American Society of Anesthesiologists (ASA) physical status I-III
  • Scheduled for elective primary total hip arthroplasty
  • Undergoing general anaesthesia
  • Provision of written informed consent to participate in the study

Exclusion Criteria:

  • Known allergy to local anaesthetics
  • Contraindications to PENG or LFCN block
  • Infection at the planned block injection site
  • Coagulopathy or anticoagulant therapy considered unsuitable for regional anaesthesia
  • Chronic opioid use
  • Significant neurological disorders that may interfere with EEG assessment
  • Cognitive impairment preventing comprehension of the study protocol or provision of informed consent
  • Inability to perform SedLine monitoring
  • Inability to obtain written informed consent

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:PENG + LFCN Block Group

Patients in this group will receive ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks before general anaesthesia. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50.

Ultrasound-guided pericapsular nerve group (PENG) and lateral femoral cutaneous nerve (LFCN) blocks will be performed before induction of general anaesthesia. Both blocks will be administered as part of a combined regional anaesthesia technique to provide perioperative analgesia during total hip arthroplasty.

有源比较器:No Intervention Group

Patients in this group will undergo general anaesthesia without preoperative peripheral nerve blocks. General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50.

General anaesthesia will be induced with propofol titrated according to EEG-derived Patient State Index (PSI) values and maintained with sevoflurane, targeting a PSI range of 25-50. Remifentanil will be administered intraoperatively according to a standardized anaesthetic protocol.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Intraoperative Sevoflurane Consumption (ml/h)
大体时间:From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

Intraoperative sevoflurane consumption will be recorded in millilitres (mL) using the anaesthesia workstation. Hourly sevoflurane consumption will be calculated by dividing the total consumption by the duration of sevoflurane administration in hours.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

次要结果测量

结果测量
措施说明
大体时间
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
大体时间:From initiation to discontinuation of remifentanil infusion during general anaesthesia.

Weight-adjusted hourly remifentanil consumption will be determined by dividing the total administered remifentanil dose (µg) by patient body weight (kg) and the duration of remifentanil infusion in hours.

From initiation to discontinuation of remifentanil infusion during general anaesthesia.
Mean Intraoperative Patient State Index (PSI)
大体时间:From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The mean Patient State Index (PSI) during sevoflurane anaesthesia will be determined using continuous EEG monitoring data obtained from the SedLine system.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Mean Intraoperative Suppression Ratio (SR)
大体时间:From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The mean suppression ratio (SR) will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia and expressed as a percentage (%).

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Percentage of Time With Suppression Ratio Above 5%
大体时间:From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.

The percentage of time during which the suppression ratio (SR) exceeds 5% will be determined using continuous EEG monitoring data obtained from the SedLine system during sevoflurane anaesthesia.

From initiation of sevoflurane administration after tracheal intubation until discontinuation of sevoflurane at the end of surgery.
Time to Extubation (min)
大体时间:From discontinuation of sevoflurane administration until tracheal extubation.

Time to extubation will be defined as the interval between discontinuation of sevoflurane administration and removal of the endotracheal tube, expressed in minutes.

From discontinuation of sevoflurane administration until tracheal extubation.
Postoperative Richmond Agitation-Sedation Scale (RASS) Score
大体时间:At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Postoperative sedation and agitation will be assessed using the Richmond Agitation-Sedation Scale (RASS) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from -5 (unarousable) to +4 (combative), with 0 indicating an alert and calm state.

At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).
Postoperative Nursing Delirium Screening Scale (NuDESC) Score
大体时间:At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

Postoperative delirium-related symptoms will be assessed using the Nursing Delirium Screening Scale (NuDESC) at 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU). Scores range from 0 to 10, with higher scores indicating more pronounced delirium-related symptoms.

At 10, 15, 30, and 45 minutes after admission to the post-anaesthesia care unit (PACU).

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年12月1日

初级完成 (估计的)

2027年5月1日

研究完成 (估计的)

2027年5月1日

研究注册日期

首次提交

2026年10月23日

首先提交符合 QC 标准的

2026年10月23日

首次发布 (实际的)

2026年10月29日

研究记录更新

最后更新发布 (实际的)

2026年11月4日

上次提交的符合 QC 标准的更新

2026年11月2日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

其他研究编号

  • PENG-LFCN-THA-2026

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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