Skip to main content
OpenTrials
Completed

NCT Number: NCT07404995

Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery

Tethered Cord Syndrome is a developmental anomaly of neuroaxis characterized by stretching of the spinal cord and is diagnosed in the pediatric age group. Surgical release of the tight and tethered filum terminale is performed. Intraoperative neurophysiological monitoring (IONM) is used to preserve functional nerve tissue and prevent postoperative neurological deficits. Total intravenous anesthesia (TIVA-TCI) with propofol and remifentanil is used as the anesthesia method to ensure accurate measurements. Postoperative pain is acute pain caused by surgical trauma and signal transmission in afferent neurons. Pediatric postoperative pain is associated with adverse behaviors, prolonged hospital stay, and impaired functional recovery. Although good progress has been made in pain management, ineffective postoperative pain management in children remains a global problem. Regional anesthesia is increasingly used in pediatric patients to provide postoperative analgesia and support intraoperative anesthesia. Ultrasound-guided erector spinae plane block (ESPB) is a new approach. First introduced in 2016 by Forero et al., ESPB is a novel regional anesthesia technique that blocks the branches of spinal nerves by injecting a local anesthetic into the fascial plane between the erector spinae muscle and the transverse process. The aim of our study was to reduce intraoperative anesthetic drug consumption, postoperative pain levels in the first 24 hours, the need for analgesics, and unwanted side effects associated with analgesics by applying bilateral ESPB in pediatric patients operated on for Tethered Cord Syndrome. Our hypothesis in this study is that bilateral ESPB reduces intraoperative anesthetic drug consumption and the need for postoperative analgesia in pediatric patients operated on for Tethered Cord Syndrome.

Completed

Looking for future studies?

Notify Me

Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye

Bursa, 16310, Turkey (Türkiye)

About this study

Ultrasound-guided erector spinae plane block (ESPB) that aims for the ventral and dorsal rami of the spinal nerves was recently introduced in spine surgery to treat postoperative pain. ESPB was reported to be effective in scoliosis surgery as it reduced the need for analgesic drugs. Due to its relative technical simplicity, the main advantages postulated for the ESPB are few complications and minimal risk for spinal cord injury.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients whose parents have given their consent to the study

  • Patients aged 18 and under
  • Patients with ASA (American Society of Anesthesiologists) physical status I, II, and III
  • Pediatric patients who will undergo elective Tethered Cord Syndrome surgery

Exclusion criteria

Patients whose parents did not consent to participate in the study

  • Patients with ASA physical status IV and V
  • Those using anticoagulant medications
  • Allergy to local anesthetic drugs
  • Patients with a history of gastrointestinal bleeding
  • Those with infection in the area where the block is planned

Treatment and study plan

UNDER ULTRASOUND GUİDANCE ESPB BLOCK

Device

In the ESP Block group, with the patient in the prone position, the research anesthesia team will insert a block needle through the skin one level above the surgical level using a linear probe guided by USG. The needle will pass through the trapezius and erector spinae muscles, and upon reaching the transverse process (approximately 2-3 cm deep), a test dose of 0.5-1 mL of 0.9% NaCl will be applied between the erector spinae fascia and the vertebral transverse process to confirm needle placement. After confirmation of fascial opening, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine. This total volume will be diluted by half with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration. The calculated local anesthetic solution will be applied to the erector spinae region for ESPB. The same procedures will be performed on the opposite side.

Other names: ESPB BLOCK

PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE

Procedure

For the ESP Block group, under USG guidance with the patient in prone position, a linear probe will be placed in the parasagittal plane one level above the operative level, and after visualizing the transverse process with an in-plane approach, a 50 mm long block needle will be inserted through the skin. A test dose of 0.5-1 mL of 0.9% NaCl will be administered between the erector spinae fascia and the transverse process of the vertebra to confirm needle placement. After confirming that the fascia has opened, a local anesthetic volume of 2 mL per vertebral pressure will be calculated, not exceeding a maximum dose of 2 mg/kg of 0.5% bupivacaine. This total volume will be diluted halfway with 0.9% NaCl solution to prepare a 0.25% bupivacaine concentration. The calculated local anesthetic solution will be administered to the erector spinae area, and ESPB will be performed. The same procedures will be performed on the opposite side.

Other names: PLANE BLOCKS

Primary outcomes

  1. INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS.

    Time frame: İNTRAOPERATİVE

    TOTAL PROPOFOL (MİLLİGRAM) and TOTAL REMİFENTANYL (MİCROGRAM)

Secondary outcomes

  1. POSTOPERATIVE PAIN SCORES

    Time frame: POSTOPERATIVE SERVICE 0. MINUTE 30.MINUTE 12.HOURS 5. MINUTE 1. HOURS 24. HOURS 10. MINUTE 2.HOURS 15. MINUTE 4. HOURS 20. MINUTE 6.HOURS

    POSTOPERATİVE PAİN SCORE (0: NONE, 100: VERY SEVERE)

Sponsors and collaborators

Lead sponsor

Bursa Yuksek Ihtisas Training and Research Hospital

Other Gov

Registry information

Official study title

Analgesic Efficacy of Bilateral Erector Spinae Plane Block in Pediatric Tethered Cord Syndrome Surgery: A Prospective, Randomized Controlled Trial

Acronym: ESPB

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Feb 12, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.