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.

NCT07602179 | Completed

• 1 other identifier: HungGMHS/No218
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postoperative Pain; Thoracic Surgery Lung; Thoracotomy Analgesia; Regional Anesthesia

Keywords

Erector spinae plane block; Thoracic epidural analgesia; Thoracic surgery; Pediatric; Postoperative pain; Opioid consumption

Outcome Measures

Primary Outcomes (1)

• Cumulative opioid consumption within the first 72 postoperative hours

  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

Secondary Outcomes (5)

• Postoperative pain scores

  at 1hour, 2hour, 4hour, 8hour, 12hour, 18hour, 24hour, 30hour, 36hour, 42hour, 48hour, 54hour, 60hour and 72hour after surgery

• Rescue analgesic requirement

  Within 72 hours postoperatively

• Block-related characteristics

  During block performance and surgery

• Catheter-related complications

  Within 72 hours postoperatively

• Postoperative complications and adverse events

  Within 72 hours postoperatively

Study Arms (2)

Thoracic erector spinae plane block (ESPB

EXPERIMENTAL

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.

Procedure: Thoracic erector spinae plane block (ESPB)

Thoracic epidural analgesia (TEA)

ACTIVE COMPARATOR

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

Procedure: Thoracic epidural analgesia (TEA)

Interventions

Thoracic erector spinae plane block (ESPB) PROCEDURE

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.

Thoracic erector spinae plane block (ESPB

Thoracic epidural analgesia (TEA) PROCEDURE

Patients will undergo thoracic epidural catheter placement for perioperative analgesia. Continuous epidural infusion of levobupivacaine will be maintained for 72 hours postoperatively

Thoracic epidural analgesia (TEA)

Eligibility Criteria

• Age: 4 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Nguyen Dang Thu: lead
• Vietnam National Children's Hospital: collaborator

Study Sites (1)

Department of Anesthesiology, Vietnam National Children's Hospital

Hanoi, Hanoi, 100000, Vietnam

Location

Related Publications (4)

• 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.

  PMID: 37971071 BACKGROUND

• 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.

  PMID: 31602352 BACKGROUND

• 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.

  PMID: 40526440 BACKGROUND

• 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.

  PMID: 36254906 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Tea

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Ph.D. M.D

Study Record Dates

• First Submitted: May 15, 2026
• First Posted: May 22, 2026
• Study Start: January 1, 2023
• Primary Completion: December 15, 2025
• Study Completion: December 31, 2025
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)