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

NCT07426939 | Not Yet Recruiting

• 1 other identifier: TABED 1-25-1436
• Study Type: interventional
• Target: 78
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Erector Spinae Plane Block; Pediatric; Caudal Epidural Anesthesia

Keywords

espb; caudal block; pediatric; erector spinae plane block

Outcome Measures

Primary Outcomes (1)

• FLACC pain score

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

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

Secondary Outcomes (9)

• Time to first rescue analgesia

  Up to 24 hours postoperatively

• Duration of Effective Analgesia

  Up to 24 hours postoperatively

• Duration of Anesthesia

  Intraoperative period

• Duration of Surgery

  Intraoperative period

• Block Performance Time

  Intraoperative period

Study Arms (2)

Caudal Block Group

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided caudal epidural block with bupivacaine.

Procedure: caudal block

Erector spinae plane block group

ACTIVE COMPARATOR

Participants will receive an ultrasound-guided erector spinae plane block with bupivacaine.

Procedure: Erector Spinae Plane Block

Interventions

caudal block PROCEDURE

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

Caudal Block Group

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.

Erector spinae plane block group

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Officials

• Zeki D Kuvet

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vildan Ergen, Associate Professor

CONTACT

905321511040; vildanergen06@gmail.com

Zeki D Kuvet, MD

CONTACT

905397959579; zekidemirhankuvet@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: February 23, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 11, 2026

Record last verified: 2025-10