Analgesic Efficacy and Hemodynamic Stability of Ultrasound-guided Thoracic Erector Spinae Plane Block Versus Thoracic Epidural Analgesia in Pediatric Thoracic Surgery: a Randomized Controlled Trial.
調査の概要
状態
詳細な説明
This prospective, single-center, randomized controlled trial was conducted in the Department of Anesthesiology at Vietnam National Children's Hospital between January 2024 and December 2024 after approval by the institutional review board. Written informed consent was obtained from the patients' parents or legal guardians before enrollment. The study was conducted in accordance with the Declaration of Helsinki and reported following the CONSORT guidelines.
Children aged 4-16 years with ASA physical status I-II undergoing elective unilateral thoracic surgery under general anesthesia were enrolled. Eligible procedures included surgery for pulmonary cysts, mediastinal tumors, diaphragmatic hernia, lung tumors, and chest wall tumors. Patients with allergy to local anesthetics, significant hepatic, renal, or cardiovascular disease, coagulation disorders, untreated hypovolemia, infection at the puncture site, spinal or chest wall deformities, or paravertebral tumors near the puncture level were excluded. Patients were withdrawn if consent was withdrawn, if major intraoperative bleeding (>20 mL/kg) occurred, or if conversion to median sternotomy was required.
After enrollment, patients were randomly assigned in a 1:1 ratio to one of the following study groups:
- ESPB group: After induction of general anesthesia, patients underwent ultrasound-guided erector spinae plane block at the T5-T6 or T6-T7 level using a high-frequency linear probe. Following hydrodissection confirmation, 0.25% levobupivacaine (0.3 mL/kg, maximum 20 mL) was injected and a catheter was inserted for continuous postoperative analgesia.
- TEA group: After induction of general anesthesia, patients underwent thoracic epidural catheter placement at the T5-T6 or T6-T7 interspace using the loss-of-resistance technique with a Tuohy needle. After confirmation of correct placement, 0.25% levobupivacaine (0.3 mL/kg, maximum 20 mL) was administered through the epidural catheter.
General anesthesia was induced with midazolam (0.03 mg/kg), fentanyl (2 µg/kg), propofol (3 mg/kg), and atracurium (0.6 mg/kg). Following endotracheal intubation, mechanical ventilation was adjusted to maintain EtCO₂ between 30-40 mmHg. One-lung ventilation was established using an Arndt bronchial blocker under fiberoptic guidance. Anesthesia was maintained with sevoflurane in an oxygen-air mixture to maintain a bispectral index between 40 and 60. Additional fentanyl (1 µg/kg) was administered when heart rate or blood pressure increased by more than 20% from baseline values despite adequate anesthetic depth. At the end of surgery, all patients received intravenous paracetamol (15 mg/kg). Postoperative pain was assessed using the Faces Pain Scale-Revised (FPS-R) at rest and during movement. Multimodal analgesia included paracetamol every 6 hours and continuous infusion of 0.125% levobupivacaine via catheter. If FPS-R scores were ≥4, a bolus dose of levobupivacaine was administered through the catheter. Intravenous morphine (0.05 mg/kg) was used as rescue analgesia when pain remained uncontrolled
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Hanoi
-
Hanoi、Hanoi、ベトナム、100000
- Department of Anesthesiology, Vietnam National Children's Hospital
-
-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) physical status I-II.
- Diagnosis of pulmonary cyst, mediastinal tumor, diaphragmatic hernia, lung tumor, or chest wall tumor requiring unilateral thoracic surgery.
Exclusion Criteria:
- Known allergy to local anesthetics;
- Significant hepatic, renal, or cardiovascular disease;
- Coagulation disorders or untreated hypovolemia;
- Infection at the puncture site;
- Spinal or chest wall deformity or paravertebral tumors near the puncture level.
- Patients were withdrawn from the study if consent was withdrawn, if major intraoperative complications occurred such as massive bleeding (>20 mL/kg), or if conversion to median sternotomy was required during surgery.
- Patient's parents who do not consent to participate in the study
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 |
|---|---|
|
実験的:Thoracic erector spinae plane block (ESPB
Patients will receive ultrasound-guided thoracic ESPB before surgical incision.
After induction of general anesthesia, a high-frequency linear ultrasound probe will be used to identify the transverse process and erector spinae muscle at the appropriate thoracic level.
A bolus dose of levobupivacaine 0.25% at 0.3 mL/kg will be injected into the erector spinae plane, followed by catheter placement for continuous postoperative analgesia.
Continuous infusion of levobupivacaine 0.125% at 0.2 mL/kg/h will be maintained for 72 postoperative hours.
|
Patients will receive ultrasound-guided thoracic ESPB before surgical incision.
After induction of general anesthesia, a high-frequency linear ultrasound probe will be used to identify the transverse process and erector spinae muscle at the appropriate thoracic level.
A bolus dose of levobupivacaine 0.25% at 0.3 mL/kg will be injected into the erector spinae plane, followed by catheter placement for continuous postoperative analgesia.
Continuous infusion of levobupivacaine 0.125% at 0.2 mL/kg/h will be maintained for 72 postoperative hours.
|
|
アクティブコンパレータ:Thoracic epidural analgesia (TEA)
Patients will receive thoracic epidural analgesia before surgical incision.
After induction of general anesthesia, an epidural catheter will be inserted at the thoracic level under sterile conditions using the loss-of-resistance technique.
A bolus dose of levobupivacaine 0.25% at 0.3 mL/kg will be administered via the epidural catheter, followed by continuous postoperative infusion of levobupivacaine 0.125% at 0.2 mL/kg/h for 72 postoperative hours
|
Patients will undergo thoracic epidural catheter placement for perioperative analgesia.
Continuous epidural infusion of levobupivacaine will be maintained for 72 hours postoperatively
|
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 |
|---|---|---|
|
Cumulative opioid consumption within the first 72 postoperative hours
時間枠:From induction of anesthesia until 72 hours postoperatively
|
Total opioid consumption included intraoperative fentanyl and postoperative rescue morphine administration.
Intraoperative fentanyl consumption was recorded during surgery, while rescue morphine was administered when postoperative FPS-R score at rest ≥4 despite rescue local anesthetic bolus
|
From induction of anesthesia until 72 hours postoperatively
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Postoperative pain scores
時間枠:at 1hour, 2hour, 4hour, 8hour, 12hour, 18hour, 24hour, 30hour, 36hour, 42hour, 48hour, 54hour, 60hour and 72hour after surgery
|
Postoperative pain was assessed using the Faces Pain Scale-Revised (FPS-R) at rest and during movement at predefined postoperative time points
|
at 1hour, 2hour, 4hour, 8hour, 12hour, 18hour, 24hour, 30hour, 36hour, 42hour, 48hour, 54hour, 60hour and 72hour after surgery
|
|
Rescue analgesic requirement
時間枠:Within 72 hours postoperatively
|
The number of patients requiring rescue morphine and total rescue morphine consumption were recorded
|
Within 72 hours postoperatively
|
|
Block-related characteristics
時間枠:During block performance and surgery
|
Block failure was defined as intraoperative fentanyl requirement >4 mcg/kg.
|
During block performance and surgery
|
|
Catheter-related complications
時間枠:Within 72 hours postoperatively
|
Catheter dislodgement, catheter occlusion, vascular puncture, and other catheter-related adverse events were recorded
|
Within 72 hours postoperatively
|
|
Postoperative complications and adverse events
時間枠:Within 72 hours postoperatively
|
Postoperative nausea and vomiting, urinary retention, pruritus, tremor, respiratory complications, and other adverse events were evaluated
|
Within 72 hours postoperatively
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Aksu C, Gurkan Y. Defining the Indications and Levels of Erector Spinae Plane Block in Pediatric Patients: A Retrospective Study of Our Current Experience. Cureus. 2019 Aug 8;11(8):e5348. doi: 10.7759/cureus.5348.
- Bosenberg A. Erector spinae plane blocks: A narrative update. Paediatr Anaesth. 2024 Mar;34(3):212-219. doi: 10.1111/pan.14800. Epub 2023 Nov 16.
- Marhofer P, Zadrazil M, Opfermann PL. Pediatric Regional Anesthesia: A Practical Guideline for Daily Clinical Practice. Anesthesiology. 2025 Aug 1;143(2):444-461. doi: 10.1097/ALN.0000000000005554. Epub 2025 Jun 17.
- Singh S, Andaleeb R, Lalin D. Can ultrasound-guided erector spinae plane block replace thoracic epidural analgesia for postoperative analgesia in pediatric patients undergoing thoracotomy? A prospective randomized controlled trial. Ann Card Anaesth. 2022 Oct-Dec;25(4):429-434. doi: 10.4103/aca.aca_269_20.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
追加の関連 MeSH 用語
その他の研究ID番号
- HungGMHS/No218
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。