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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07147062
Enrollment
65
Registered
2025-08-28
Start date
2025-09-08
Completion date
2026-02-27
Last updated
2025-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Percutaneous Internal Ring Suturing, Pain Management

Keywords

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

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.

Interventions

PROCEDURERectus 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.

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.

Sponsors

Diskapi Yildirim Beyazit Education and Research Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
1 Years to 8 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Pain ScoresOn the operation dayPain 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

MeasureTime frameDescription
Postoperative nausea and vomitingOn the operation dayThe occurrence of postoperative nausea and vomiting (PONV) and the number of episodes will be recorded.
Time to first mobilizationOn the operation dayTime to first mobilization will be recorded in hours after surgery.

Countries

Turkey (Türkiye)

Contacts

Primary ContactElif Şule Özdemir Sezgi
elifsule-91@hotmail.com00905059209638
Backup ContactAslı Dönmez
aslidonmez@hotmail.com00905322256473

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026