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

February 9, 2026 updated by: sermın emınoglu, Bursa Yuksek Ihtisas Training and Research Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
73

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Bursa
      • Bursa, Bursa, Turkey (Türkiye), 16310
        • Bursa yüksek ihtisas eğitim ve araştırma hastanesi BURSA, Bursa, Türkiye

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UNDER ULTRASOUND GUİDANCE ESPB GROUP
Under ultrasound guidance, bilateral erector spinae plane block will be performed on the ESPB group one level above the appropriate area for pediatric tethered cord surgery using the anesthetic drug bupivacaine.
Device: UNDER ULTRASOUND GUİDANCE ESPB BLOCK
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: PROCEDURE/SURGERY: ERECTOR SPİNAE (ESP) BLOCK WİTH BUPİVACAİNE
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
INTRAOPERATİVE ANESTHETİC DRUG CONSUMPTİON BY APPLYİNG BİLATERAL ESPB İN PEDİATRİC PATİENTS.
Time Frame: İNTRAOPERATİVE
TOTAL PROPOFOL (MİLLİGRAM) and TOTAL REMİFENTANYL (MİCROGRAM)
İNTRAOPERATİVE

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bursa Yuksek Ihtisas Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 9, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2024-KAEK-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study protocol and results can be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erector Spina Plan Block

Clinical Trials on UNDER ULTRASOUND GUİDANCE ESPB BLOCK

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings