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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.

15 mai 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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

Type d'étude

Interventionnel

Inscription (Réel)

70

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Enfant

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Seul

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Procédure: 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.
Comparateur actif: 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
Procédure: Thoracic epidural analgesia (TEA)
Patients will undergo thoracic epidural catheter placement for perioperative analgesia. Continuous epidural infusion of levobupivacaine will be maintained for 72 hours postoperatively

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Cumulative opioid consumption within the first 72 postoperative hours
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Postoperative pain scores
Délai: 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
Délai: 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
Délai: During block performance and surgery
Block failure was defined as intraoperative fentanyl requirement >4 mcg/kg.
During block performance and surgery
Catheter-related complications
Délai: 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
Délai: Within 72 hours postoperatively
Postoperative nausea and vomiting, urinary retention, pruritus, tremor, respiratory complications, and other adverse events were evaluated
Within 72 hours postoperatively

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Nguyen Dang Thu

Collaborateurs

Vietnam National Children's Hospital

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

1 janvier 2023

Achèvement primaire (Réel)

15 décembre 2025

Achèvement de l'étude (Réel)

31 décembre 2025

Dates d'inscription aux études

Première soumission

15 mai 2026

Première soumission répondant aux critères de contrôle qualité

15 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • HungGMHS/No218

Plan pour les données individuelles des participants (IPD)

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NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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