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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.

2026년 5월 15일 업데이트: 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.

연구 개요

상세 설명

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

연구 유형

중재적

등록 (실제)

70

단계

  • 해당 없음

연락처 및 위치

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연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
활성 비교기: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Cumulative opioid consumption within the first 72 postoperative hours
기간: 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

2차 결과 측정

결과 측정
측정값 설명
기간
Postoperative pain scores
기간: 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
기간: 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
기간: During block performance and surgery
Block failure was defined as intraoperative fentanyl requirement >4 mcg/kg.
During block performance and surgery
Catheter-related complications
기간: 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
기간: Within 72 hours postoperatively
Postoperative nausea and vomiting, urinary retention, pruritus, tremor, respiratory complications, and other adverse events were evaluated
Within 72 hours postoperatively

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연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2023년 1월 1일

기본 완료 (실제)

2025년 12월 15일

연구 완료 (실제)

2025년 12월 31일

연구 등록 날짜

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2026년 5월 15일

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2026년 5월 15일

처음 게시됨 (실제)

2026년 5월 22일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 15일

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2026년 5월 1일

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