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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.

2026年5月15日 更新者:Nguyen Dang Thu
Thoracic surgery in children is considered a highly invasive procedure that significantly affects respiratory mechanics and cardiovascular function, resulting in substantial physiological disturbances during the perioperative period. In pediatric patients, the chest wall is structurally immature and highly compliant; therefore, impairment of ventilation after thoracic surgery may persist and predispose to atelectasis, hypoxemia, and other pulmonary complications. Inadequate postoperative analgesia may further compromise respiratory function, delay mobilization, and prolong recovery, particularly during the first 48-72 hours after thoracic surgery, when pain intensity is typically greatest. Thoracic epidural analgesia (TEA) has long been regarded as the reference technique for postoperative pain control in thoracic surgery. However, in pediatric patients, epidural catheter placement may be technically challenging and is associated with potential adverse effects such as hypotension, bradycardia, urinary retention, and other neuraxial-related complications. Thoracic epidural blockade produces bilateral sympathetic inhibition, which may lead to hemodynamic instability, particularly during thoracic surgery requiring lateral decubitus positioning and one-lung ventilation. Furthermore, epidural placement is often performed after induction of general anesthesia in children, which may limit early recognition of neurological complications. These concerns highlight the need for alternative regional analgesic techniques that provide effective analgesia while maintaining hemodynamic stability. Ultrasound-guided erector spinae plane block (ESPB) has recently emerged as a promising fascial plane block for thoracic analgesia. Injection of local anesthetic deep to the erector spinae muscle and superficial to the transverse process allows cranio-caudal spread across multiple dermatomes, potentially providing analgesia to the posterior, lateral, and anterior thoracic walls. Increasing evidence suggests that ESPB offers effective perioperative analgesia in thoracic surgery with a favorable safety profile and minimal sympathetic blockade. Continuous ESPB catheter techniques have also been reported to provide sustained postoperative analgesia comparable to epidural analgesia. Despite these encouraging findings, direct comparisons between continuous ESPB and TEA in pediatric thoracic surgery remain limited, particularly regarding hemodynamic effects, adverse events, and technical feasibility. Therefore, this randomized controlled trial was conducted to compare the analgesic efficacy and hemodynamic stability of continuous ultrasound-guided thoracic ESPB with thoracic epidural analgesia in children undergoing thoracic surgery.

研究概览

详细说明

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

研究类型

介入性

注册 (实际的)

70

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。

学习地点

    • Hanoi
      • Hanoi、Hanoi、越南、100000
        • Department of Anesthesiology, Vietnam National Children's Hospital

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

  • 孩子

接受健康志愿者

不

描述

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

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: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.
有源比较器: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

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
Cumulative opioid consumption within the first 72 postoperative hours
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Postoperative pain scores
大体时间: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
大体时间: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
大体时间:During block performance and surgery
Block failure was defined as intraoperative fentanyl requirement >4 mcg/kg.
During block performance and surgery
Catheter-related complications
大体时间: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
大体时间:Within 72 hours postoperatively
Postoperative nausea and vomiting, urinary retention, pruritus, tremor, respiratory complications, and other adverse events were evaluated
Within 72 hours postoperatively

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 (实际的)

2023年1月1日

初级完成 (实际的)

2025年12月15日

研究完成 (实际的)

2025年12月31日

研究注册日期

首次提交

2026年5月15日

首先提交符合 QC 标准的

2026年5月15日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月15日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

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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