Subcostal TAP Block and EEG Dynamics in Laparoscopic Cholecystectomy
Effect of Subcostal Transversus Abdominis Plane Block on Analgesia, EEG Dynamics, and Burst Suppression in Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy is a commonly performed minimally invasive surgical procedure. Despite its minimally invasive nature, surgical stimulation and pneumoperitoneum may cause pain-related physiological and neurophysiological responses during general anesthesia.
This prospective observational study will evaluate patients undergoing laparoscopic cholecystectomy under general anesthesia. Patients will be observed according to the analgesic technique selected by the attending anesthesiologist as part of routine clinical care: intravenous remifentanil alone or remifentanil combined with an ultrasound-guided subcostal transversus abdominis plane (TAP) block.
The study will examine the relationship between the use of subcostal TAP block and intraoperative analgesic requirements, Bispectral Index (BIS) values, electroencephalographic (EEG) dynamics, and burst suppression. Postoperative pain scores, additional analgesic requirements, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction will also be evaluated.
調査の概要
状態
詳細な説明
This is a prospective, single-center observational study including adult patients scheduled for laparoscopic cholecystectomy under general anesthesia. The study will be conducted at Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital.
Perioperative analgesic management will be determined by the attending anesthesiologist according to routine clinical practice and will not be assigned by the study protocol. Patients will subsequently be evaluated in two observational groups according to the analgesic technique received. One group will consist of patients receiving intravenous remifentanil infusion without a subcostal TAP block, while the other group will consist of patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal TAP block.
General anesthesia will be maintained using sevoflurane and remifentanil according to routine clinical practice. Depth of anesthesia and cerebral electrical activity will be monitored using Bispectral Index (BIS) monitoring and electroencephalography (EEG). Intraoperative EEG characteristics, including changes in alpha-band activity and burst suppression, as well as BIS values, will be recorded and compared between the two groups.
Intraoperative analgesic consumption, including remifentanil and additional fentanyl use, will be recorded from anesthesia records. Hemodynamic responses and other routinely monitored parameters will also be documented.
Postoperative pain will be evaluated using the Numerical Rating Scale (NRS) at rest and during activity at 0, 1, 4, 8, 12, and 24 hours after surgery. Routine postoperative analgesia includes intravenous paracetamol and tenoxicam. When clinically indicated for inadequate pain control, rescue analgesia with intravenous tramadol may be administered according to routine clinical practice, and additional analgesic consumption will be recorded.
Postoperative recovery will additionally be assessed using the 15-item Quality of Recovery questionnaire (QoR-15). Mobilization time, length of hospital stay, and patient satisfaction will also be recorded.
The primary objective of the study is to evaluate the association between subcostal TAP block use and intraoperative analgesic requirements, anesthetic depth, EEG dynamics, and burst suppression. Secondary objectives include comparison of postoperative pain, additional analgesic consumption, quality of recovery, mobilization time, length of hospital stay, and patient satisfaction between the two groups.
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Istanbul、トルコ(Türkiye)
- 募集
- Sancaktepe Sehit Prof. Dr. Ilhan Varank Training and Research Hospital
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コンタクト:
- Department of Anesthesiology and Reanimation, MD
- 電話番号:+90 216 606 33 00
- メール:sancaktepeetikkurul@gmail.com
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コンタクト:
- Ezgi Erdag, MD
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主任研究者:
- Nurten Bakan
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Age 18 years or older
- American Society of Anesthesiologists (ASA) physical status I-III
- Scheduled to undergo laparoscopic cholecystectomy under general anesthesia
- Written informed consent provided by the participant or, when applicable, the legally authorized representative
Exclusion Criteria:
- Refusal to participate in the study
- American Society of Anesthesiologists (ASA) physical status IV-V
- Known allergy or hypersensitivity to medications used during perioperative anesthetic or analgesic management
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Remifentanil Group
Patients receiving intravenous remifentanil infusion without a subcostal TAP block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
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Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
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Remifentanil + Subcostal TAP Block Group
Patients receiving intravenous remifentanil infusion together with an ultrasound-guided subcostal transversus abdominis plane (TAP) block as part of routine perioperative analgesic management during laparoscopic cholecystectomy.
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Intravenous remifentanil infusion administered as part of routine general anesthesia and perioperative analgesic management.
Ultrasound-guided subcostal transversus abdominis plane block performed as part of routine perioperative analgesic management according to the attending anesthesiologist's clinical decision.
他の名前:
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Total Intraoperative Remifentanil Consumption
時間枠:From induction of general anesthesia until the end of surgery
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Total amount of intravenous remifentanil administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the remifentanil-only group and the remifentanil plus subcostal TAP block group.
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From induction of general anesthesia until the end of surgery
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Intraoperative Bispectral Index Values
時間枠:From induction of general anesthesia until the end of surgery
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Bispectral Index (BIS) values recorded during general anesthesia will be evaluated to assess anesthetic depth and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Intraoperative EEG Alpha-Band Activity
時間枠:From induction of general anesthesia until the end of surgery
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Changes in electroencephalographic alpha-band activity during general anesthesia and surgical stimulation will be recorded and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Intraoperative Burst Suppression
時間枠:From induction of general anesthesia until the end of surgery
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Burst suppression observed on intraoperative EEG monitoring during general anesthesia will be recorded and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Total Intraoperative Fentanyl Consumption
時間枠:From induction of general anesthesia until the end of surgery
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The total dose of intravenous fentanyl administered during laparoscopic cholecystectomy will be recorded from the anesthesia record and compared between the two observational groups.
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From induction of general anesthesia until the end of surgery
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Postoperative Pain at Rest
時間枠:At 0, 1, 4, 8, 12, and 24 hours after surgery
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Pain intensity at rest will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.
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At 0, 1, 4, 8, 12, and 24 hours after surgery
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Postoperative Pain During Activity
時間枠:At 0, 1, 4, 8, 12, and 24 hours after surgery
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Pain intensity during activity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Measurements will be recorded at 0, 1, 4, 8, 12, and 24 hours after surgery.
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At 0, 1, 4, 8, 12, and 24 hours after surgery
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Total Postoperative Rescue Tramadol Consumption
時間枠:During the first 24 hours after surgery
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The total dose of intravenous tramadol administered as rescue analgesia for postoperative pain with an NRS score of 4 or greater will be recorded.
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During the first 24 hours after surgery
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Quality of Recovery-15 Score
時間枠:At 24 hours after surgery
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Postoperative quality of recovery will be assessed using the 15-item Quality of Recovery questionnaire (QoR-15).
The total score ranges from 0 to 150, with higher scores indicating better quality of recovery.
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At 24 hours after surgery
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Time to First Mobilization
時間枠:Up to 24 hours after surgery
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The time from completion of surgery to the patient's first postoperative mobilization will be recorded.
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Up to 24 hours after surgery
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Length of Hospital Stay
時間枠:From completion of surgery until hospital discharge Up to 7 days
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The duration of postoperative hospital stay will be recorded and compared between the two observational groups.
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From completion of surgery until hospital discharge Up to 7 days
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協力者と研究者
出版物と役立つリンク
一般刊行物
- Anders M, Anders B, Dreismickenbecker E, Hight D, Kreuzer M, Walter C, Zinn S. EEG responses to standardised noxious stimulation during clinical anaesthesia: a pilot study. BJA Open. 2022 Dec 30;5:100118. doi: 10.1016/j.bjao.2022.100118. eCollection 2023 Mar.
- MacKay EC, Sleigh JW, Voss LJ, Barnard JP. Episodic waveforms in the electroencephalogram during general anaesthesia: a study of patterns of response to noxious stimuli. Anaesth Intensive Care. 2010 Jan;38(1):102-12. doi: 10.1177/0310057X1003800118.
- Bublitz V, Jurth C, Kreuzer M, Lichtner G, von Dincklage F. Electroencephalogram-based prediction and detection of responsiveness to noxious stimulation in critical care patients: a retrospective single-centre analysis. Br J Anaesth. 2023 Feb;130(2):e339-e350. doi: 10.1016/j.bja.2022.09.031. Epub 2022 Nov 19.
- Garcia PS, Kreuzer M, Hight D, Sleigh JW. Effects of noxious stimulation on the electroencephalogram during general anaesthesia: a narrative review and approach to analgesic titration. Br J Anaesth. 2021 Feb;126(2):445-457. doi: 10.1016/j.bja.2020.10.036.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
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
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- TAPEEG-LC-2026-01
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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