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

NCT ID: NCT07147062

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-08

Study Completion Date

2026-02-27

Brief Summary

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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.

Detailed Description

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Conditions

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Percutaneous Internal Ring Suturing Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Rectus Sheath Block

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.

Group Type ACTIVE_COMPARATOR

Rectus Sheath Block

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Caudal Epidural Block

Intervention Type 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.

Interventions

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Rectus Sheath Block

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.

Intervention Type PROCEDURE

Caudal Epidural Block

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Yildirim Beyazit Education and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Elif Sule Ozdemir

Principal İnvestigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara Etlik City Hospital

Altındağ, Ankara, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Elif Şule Özdemir Sezgi

Role: CONTACT

00905059209638

Aslı Dönmez

Role: CONTACT

00905322256473

Facility Contacts

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Elif Şule Özdemir Sezgi, M.D.

Role: primary

00905059209638

Aslı Dönmez, Professor

Role: backup

00905322256473

Other Identifiers

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AEŞH-EK-2025-170

Identifier Type: -

Identifier Source: org_study_id

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