Multimodal Fascial Plane Block for Postoperative Analgesia in Isolated CABG Surgery (BLOCKCABG)
Effect of Induction-Time Multimodal Fascial Plane Block on Postoperative Analgesia and Opioid Consumption in Patients Undergoing Isolated Coronary Artery Bypass Grafting: A Prospective Randomized Controlled Trial
Postoperative pain following coronary artery bypass grafting (CABG) via median sternotomy remains a significant clinical problem and is associated with increased opioid consumption and postoperative complications. Fascial plane blocks have emerged as part of multimodal analgesia strategies in cardiac surgery.
This prospective, randomized, controlled, single-blinded study aims to evaluate the effect of an induction-time multimodal fascial plane block package-consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block-on postoperative analgesia, opioid consumption, and clinical outcomes in patients undergoing elective isolated CABG with saphenous vein graft harvesting.
Patients will be randomized in a 1:1 ratio to receive either the multimodal fascial plane block package in addition to standard postoperative analgesia or standard postoperative analgesia alone. The primary outcome is total opioid consumption within the first 24 postoperative hours. Secondary outcomes include pain scores, time to first opioid requirement, extubation time, postoperative pulmonary complications, atrial fibrillation, and length of ICU and hospital stay.
調査の概要
状態
詳細な説明
Median sternotomy, chest drains, and saphenous vein graft harvesting are major contributors to postoperative pain following CABG surgery. Inadequate pain control may impair respiratory mechanics, delay mobilization, and increase postoperative morbidity. Multimodal analgesic approaches aim to reduce opioid requirements and improve recovery profiles.
This single-center, prospective, randomized controlled trial will include adult patients (18-80 years) scheduled for elective isolated CABG with saphenous vein graft harvesting. After written informed consent, eligible participants will be randomly assigned to either the intervention group or the control group.
The intervention group will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and prior to surgical incision. The control group will receive standard perioperative analgesia without regional block. All other perioperative management will be standardized.
The primary endpoint is total opioid consumption within the first 24 hours postoperatively. Secondary endpoints include pain scores at predefined time points (6, 12, 24, and 48 hours), time to first opioid requirement, extubation time, incidence of postoperative pulmonary complications and atrial fibrillation, ICU length of stay, hospital length of stay, and time to first mobilization.
The study is designed to assess whether a multimodal fascial plane block strategy can improve postoperative analgesia and reduce opioid use in cardiac surgery patients.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Selen Topalel, MD
- 電話番号：+90 533 506 33 20
- メール：selentopalel26@gmail.com
研究場所
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Diyarbakır
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Diyarbakır、Diyarbakır、トルコ（Türkiye）
- 募集
- University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
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コンタクト：
- Selen Topalel, MD
- 電話番号：+90 533 506 33 20
- メール：selentopalel26@gmail.com
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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
説明
Inclusion Criteria:
- Age between 18 and 80 years
- Scheduled for elective isolated coronary artery bypass grafting (CABG) with saphenous vein graft harvesting
- ASA physical status II-IV
- Ability to provide written informed consent
Exclusion Criteria:
- Known coagulopathy or contraindication to regional anesthesia
- Use of anticoagulant therapy precluding regional block
- Known allergy to local anesthetics
- Local infection at planned block sites
- Chronic opioid use or chronic pain syndrome
- Emergency surgery
- Redo sternotomy
- Severe neurological disorder affecting pain assessment
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
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Multimodal Fascial Plane Block Group
Participants will receive a multimodal fascial plane block package consisting of bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block following induction of general anesthesia and before surgical incision, in addition to standard perioperative analgesia.
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Participants will receive ultrasound-guided bilateral superficial parasternal block, bilateral serratus anterior plane block, and adductor canal block after induction of general anesthesia and before surgical incision.
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アクティブコンパレータ：Standard Analgesia Group
Participants will receive standard perioperative and postoperative analgesia without regional fascial plane block intervention.
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Participants will receive standard institutional perioperative and postoperative analgesia without regional fascial plane block.
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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 |
|---|---|---|
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Total opioid consumption within the first 48 postoperative hours
時間枠：Through 48 hours after surgery
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Total cumulative tramadol consumption (mg) during the first 48 hours following surgery.
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Through 48 hours after 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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Postoperative pain intensity scores
時間枠：At 6, 12, 24, and 48 hours after surgery
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Pain intensity measured using the Numeric Rating Scale (NRS; 0-10) at rest and during movement at predefined postoperative time points.
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At 6, 12, 24, and 48 hours after surgery
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Time to first rescue analgesic requirement
時間枠：Within 48 hours after surgery
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Time from arrival to the intensive care unit to first rescue analgesic administration (hours).
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Within 48 hours after surgery
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Extubation time
時間枠：From ICU admission to extubation, assessed through 24 hours after surgery
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Time from arrival to the intensive care unit to successful tracheal extubation (hours).
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From ICU admission to extubation, assessed through 24 hours after surgery
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協力者と研究者
捜査官
- 主任研究者：Selen Topalel, MD、University of Health Sciences, Diyarbakir Gazi Yasargil Training and Research Hospital
出版物と役立つリンク
一般刊行物
- Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
- Kalli A, Vistbacka J, Moilanen E, Jarvela K, Mennander A. Superficial Parasternal Intercostal Plane Block and Full Sternotomy; A Randomized Trial. Eur J Cardiothorac Surg. 2025 Jul 1;67(7):ezaf226. doi: 10.1093/ejcts/ezaf226.
- Zhang J, Luo F, Zhang X, Xue Y. Ultrasound-Guided Continuous Parasternal Intercostal Block Relieves Postoperative Pain After Open Cardiac Surgery: A Case Series. J Cardiothorac Vasc Anesth. 2022 Jul;36(7):2051-2054. doi: 10.1053/j.jvca.2021.05.028. Epub 2021 May 21.
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
その他の研究ID番号
- GY-CABG-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?
IPD プランの説明
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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