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)
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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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.
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：AYSE SENCAN, M.D Anaesthesiology Specialist
- 電話番号：+905078313235
- メール：draysesencan@gmail.com
研究場所
-
-
Kocaeli
-
Köseköy、Kocaeli、トルコ（Türkiye）、41100
- Kocaeli City Hospital
-
コンタクト：
- AYSE SENCAN, M.D Anaesthesiology Specialist
- 電話番号：+905078313235
- メール：draysesencan@gmail.com
-
コンタクト：
- Ayse Zeynep Turan Civraz, Associated Professor
- 電話番号：+905054695850
- メール：ayse.zeynep@gmail.com
-
-
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
|
実験的：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. |
|
アクティブコンパレータ：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. |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Intraoperative Sevoflurane Consumption (ml/h)
時間枠：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.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Weight-Adjusted Intraoperative Remifentanil Consumption (µg/kg/h)
時間枠：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)
時間枠：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)
時間枠：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%
時間枠：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)
時間枠：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
時間枠：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
時間枠：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).
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Purdon PL, Sampson A, Pavone KJ, Brown EN. Clinical Electroencephalography for Anesthesiologists: Part I: Background and Basic Signatures. Anesthesiology. 2015 Oct;123(4):937-60. doi: 10.1097/ALN.0000000000000841.
- Pawar N, Barreto Chang OL. Burst Suppression During General Anesthesia and Postoperative Outcomes: Mini Review. Front Syst Neurosci. 2022 Jan 7;15:767489. doi: 10.3389/fnsys.2021.767489. eCollection 2021.
- Carella M, Bugada D, Van de Velde M, Beloeil H, Albrecht E, Lavandhomme P, Raeder J, Joshi GP; PROSPECT Working Group of the European Society of Regional Anesthesia and Pain Therapy. PROSPECT guideline for total hip arthroplasty: updated systematic review and procedure-specific postoperative pain management recommendations. Anaesthesia. 2026 Jul 20. doi: 10.1111/anae.70299. Online ahead of print.
- Ozturk L, Kesimci E, Albayrak T, Kanbak O. Bispectral index-guided general anaesthesia in combination with interscalene block reduces desflurane consumption in arthroscopic shoulder surgery: a clinical comparison of bupivacaine versus levobupivacaine. BMC Anesthesiol. 2015 Jul 21;15:104. doi: 10.1186/s12871-015-0087-8.
- Musizza B, Ribaric S. Monitoring the depth of anaesthesia. Sensors (Basel). 2010;10(12):10896-935. doi: 10.3390/s101210896. Epub 2010 Dec 3.
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
その他の研究ID番号
- PENG-LFCN-THA-2026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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