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NCT Number: NCT07426939

Comparison of Erector Spinae Plane Block and Caudal Block in Pediatric Patients Aged 1 to 8 Years Undergoing Lower Abdominal Surgery

In routine pediatric surgical practice, lower abdominal surgeries are commonly performed. Inadequate control of postoperative pain can hinder functional recovery and may lead to negative behavioral changes as well as parental dissatisfaction. Regional anesthesia techniques are widely recommended for pain management in pediatric surgery, as they reduce the need for parenteral opioids and improve the effectiveness of postoperative pain control, patient comfort, and parental satisfaction.

Various nerve block techniques have been developed to enhance postoperative analgesia and facilitate recovery in pediatric patients. However, there is still no consensus regarding the most effective regional anesthesia strategy for pediatric surgical procedures.

Among regional anesthesia techniques used for pain management in children undergoing lower abdominal surgery, caudal block remains the most commonly applied method. The introduction of real-time ultrasound guidance has improved the reliability and safety of caudal blocks. Nevertheless, a major limitation of this technique is its relatively short duration of action following a single injection, even when long-acting local anesthetics or adjuvant agents are used. Consequently, several fascial plane blocks, such as the quadratus lumborum block, transversus abdominis plane block, and rectus sheath block, have been proposed as alternative approaches for postoperative analgesia in children.

The erector spinae plane block is a regional anesthesia technique that has been applied at thoracic, lumbar, cervical, and sacral levels for both acute and chronic pain management. By providing blockade of both somatic and visceral pain pathways, it has demonstrated effective postoperative analgesic properties in a variety of thoracic and abdominal surgical procedures. The technique involves the injection of a local anesthetic into the interfascial plane between the erector spinae muscle and the transverse process, allowing longitudinal spread of the anesthetic across multiple spinal levels.

With a growing body of evidence supporting its feasibility and effectiveness, the erector spinae plane block has gained increasing attention in pediatric anesthesia practice.

The aim of this study is to evaluate and compare the analgesic efficacy and safety of ultrasound-guided erector spinae plane block and caudal block in pediatric patients undergoing unilateral lower abdominal surgery under general anesthesia. The primary objective is to compare postoperative pain levels between the two techniques using the FLACC score, which assesses facial expression, leg position, activity, crying, and consolability. Secondary objectives include the evaluation of intraoperative heart rate, blood pressure, and oxygen saturation, block application times, parental satisfaction, and the incidence of postoperative side effects.

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Key information

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Children aged 1 to 8 years

Scheduled for elective lower abdominal surgery

American Society of Anesthesiologists (ASA) physical status I-II

Written informed consent obtained from parent(s) or legal guardian(s)

Exclusion criteria

Presence of anatomical abnormalities

Coagulation disorders

Infection at the site of block application

Severe cardiovascular, neurological, respiratory, or metabolic disease

Known allergy to study medications

Failed regional block

Bilateral surgery or additional surgical procedures involving different surgical sites

Refusal of parent(s) or legal guardian(s) to provide consent

Treatment and study plan

Caudal block

Procedure

A single-shot ultrasound-guided caudal epidural block will be performed via the sacral hiatus using a standard technique.

Erector Spinae Plane Block

Procedure

A single-shot ultrasound-guided erector spinae plane block will be performed at the L1 transverse process level using an in-plane technique.

Primary outcomes

  1. FLACC pain score

    Time frame: 0, 30 minutes; 1, 2, 4, 8, 12, and 24 hours after surgery

    Postoperative pain will be assessed using the FLACC scale. Unit of Measure: Score (0-10)

Secondary outcomes

  1. Time to first rescue analgesia

    Time frame: Up to 24 hours postoperatively

    Time from the end of surgery to the first administration of rescue analgesic

  2. Duration of Effective Analgesia

    Time frame: Up to 24 hours postoperatively

    Time from block application to the first FLACC pain score ≥4

  3. Duration of Anesthesia

    Time frame: Intraoperative period

    Time from anesthesia induction to awake extubation

  4. Duration of Surgery

    Time frame: Intraoperative period

    Time from skin incision to skin closure

  5. Block Performance Time

    Time frame: Intraoperative period

    Time from needle insertion to completion of block procedure

  6. Intraoperative Heart Rate

    Time frame: 0, 15, 30, 45 minutes and 1 hour after inductio

    Heart rate measured intraoperatively

  7. Intraoperative Mean Arterial Pressure

    Time frame: 0, 15, 30, 45 minutes and 1 hour after induction

    Mean arterial pressure measured intraoperatively

  8. Intraoperative Oxygen Saturation

    Time frame: 0, 15, 30, 45 minutes and 1 hour after induction

    Peripheral oxygen saturation measured intraoperatively

  9. Postoperative Adverse Events

    Time frame: First 24 hours postoperatively

    Incidence of postoperative adverse events including nausea, vomiting, nerve injury, or infection

Study contacts

Contact information is provided by the study sponsor or research team.

Vildan Ergen, Associate Professor

CONTACT

[email protected]

905321511040

Zeki D Kuvet, MD

CONTACT

[email protected]

905397959579

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
May 11, 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.

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