Comparison of the Postoperative Analgesic Effects of RSB and CEB in Pediatric Patients Scheduled for Percutaneous Internal Ring Suturing

NCT07147062 | Recruiting

• 1 other identifier: AEŞH-EK-2025-170
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

Inguinal hernia is one of the most common surgical pathologies in children, and the minimally invasive percutaneous internal ring suturing (PIRS) technique is widely preferred. By providing effective pain control, nerve blocks reduce postoperative opioid requirements, thereby minimising opioid-related adverse effects and lowering the risk of pulmonary and cardiovascular complications. This study aims to compare the postoperative analgesic effects of rectus sheath block and caudal epidural block in pediatric patients undergoing PIRS.

Conditions

Percutaneous Internal Ring Suturing; Pain Management

Keywords

Percutaneous internal ring suturing; Rectus sheath block; Caudal epidural block

Outcome Measures

Primary Outcomes (1)

• Pain Scores

  Pain will be assessed at rest and during coughing using the FLACC (Face, Legs, Activity, Cry, Consolability) scale, scored from 0 to 10. Pain assessments will be performed at the 0th, 1st, 2nd, 4th, 12th, and 24th hours after surgery.

  On the operation day

Secondary Outcomes (2)

• Postoperative nausea and vomiting

  On the operation day

• Time to first mobilization

  On the operation day

Study Arms (2)

Rectus Sheath Block

ACTIVE COMPARATOR

Using an in-plane approach from cephalad to caudal, a 22G, 50-mm needle will be advanced through the subcutaneous tissues, penetrating the anterior rectus sheath and progressing within the muscle until the needle tip contacts the posterior rectus sheath. After negative aspiration, a total volume of 0.5 mL/kg of 0.25% bupivacaine-distributed equally between both sides-will be injected bilaterally under direct ultrasound guidance. Paracetamol at a dose of 10 mg/kg will be administered intraoperatively.

Procedure: Rectus Sheath Block

Caudal Epidural Block

ACTIVE COMPARATOR

A 22G caudal epidural needle will be inserted at approximately a 45° angle toward the sacral hiatus, and the characteristic "click" sensation will be felt upon passing the sacrococcygeal ligament. The needle will then be advanced carefully in the cephalad direction, parallel to the longitudinal axis of the spinal canal. After confirming correct placement by negative aspiration, 1 mL/kg of 0.25% bupivacaine will be administered. Paracetamol at a dose of 10 mg/kg will be administered intraoperatively.

Procedure: Caudal Epidural Block

Interventions

Rectus Sheath Block PROCEDURE

A total volume of 0.5 mL/kg of 0.25% bupivacaine-distributed equally between both sides-will be injected bilaterally under direct ultrasound guidance.

Rectus Sheath Block

Caudal Epidural Block PROCEDURE

A 22G caudal epidural needle will be inserted at approximately a 45° angle toward the sacral hiatus, and the characteristic "click" sensation will be felt upon passing the sacrococcygeal ligament. The needle will then be advanced carefully in the cephalad direction, parallel to the longitudinal axis of the spinal canal. After confirming correct placement by negative aspiration, 1 mL/kg of 0.25% bupivacaine will be administered.

Caudal Epidural Block

Eligibility Criteria

• Age: 1 Year - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients aged between 1 and 8 years
• ASA physical status I-II
• Patients who underwent PIRS surgery in the operating room and received either a rectus sheath block or a caudal epidural block

You may not qualify if:

• Patients younger than 1 year or older than 8 years
• ASA physical status ≥ III
• History of bleeding diathesis

Sponsors & Collaborators

• Diskapi Yildirim Beyazit Education and Research Hospital: lead

Study Sites (1)

Ankara Etlik City Hospital

Altındağ, Ankara, 06000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elif Şule Özdemir Sezgi

CONTACT

00905059209638; elifsule-91@hotmail.com

Aslı Dönmez

CONTACT

00905322256473; aslidonmez@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal İnvestigator

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: August 28, 2025
• Study Start: September 8, 2025
• Primary Completion: February 13, 2026
• Study Completion: February 27, 2026
• Last Updated: September 9, 2025

Record last verified: 2025-09

Locations

TU (1)