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

ConditionsPercutaneous Internal Ring SuturingPain Management
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-8
SponsorDiskapi Yildirim Beyazit Education and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients younger than 1 year or older than 8 years

ASA physical status ≥ III

History of bleeding diathesis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Rectus Sheath Block

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

65 Participants
are divided into 2 treatment groups
Group A: Rectus Sheath BlockActive comparator 1 intervention
Group B: Caudal Epidural BlockActive comparator 1 intervention

Trial outcomes

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.

Time frame
On the operation day

Secondary outcomes

1

Postoperative nausea and vomiting

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

Time frame
On the operation day
2

Time to first mobilization

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

Time frame
On the operation day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Diskapi Yildirim Beyazit Education and Research Hospital

Lead sponsor

Ankara Etlik City Hospital

Sponsor institution

Source ClinicalTrials.gov
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