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NCT Number: NCT07147062

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

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.

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Key information

Conditions

Percutaneous Internal Ring Suturing Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Management Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

1 year–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Scores

    Time frame: On the operation day

    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.

Secondary outcomes

  1. Postoperative nausea and vomiting

    Time frame: On the operation day

    The occurrence of postoperative nausea and vomiting (PONV) and the number of episodes will be recorded.

  2. Time to first mobilization

    Time frame: On the operation day

    Time to first mobilization will be recorded in hours after surgery.

Study contacts

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

Aslı Dönmez

CONTACT

[email protected]

00905322256473

Elif Şule Özdemir Sezgi

CONTACT

[email protected]

00905059209638

Sponsors and collaborators

Lead sponsor

Diskapi Yildirim Beyazit Education and Research Hospital

Other Gov

Registry information

Official study title

Comparison of the Postoperative Analgesic Effects of Rectus Sheath Block and Caudal Epidural Block in Pediatric Patients Scheduled for Percutaneous Internal Ring Suturing

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2025
Registry last updated
Sep 9, 2025

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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