Caudal Block vs Retrolaminar Block on Analgesic Consumption in Undescended Testis Surgeries

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age1-7
SponsorKanuni Sultan Suleyman Training and Research Hospital

About this trial

This study compares the postoperative analgesic effectiveness of Caudal Block (CB) and Retrolaminar Block (RLB) in pediatric patients undergoing undescended testis surgeries. Both techniques aim to manage pain effectively and reduce reliance on systemic analgesics, improving recovery and minimizing complications.

The double-blind, randomized controlled trial will include 1-7-year-old ASA I-II patients at two hospitals. Patients with specific contraindications (e.g., spinal anomalies, allergies, or infections) will be excluded. Randomization divides participants into two groups (CB and RLB), with pain assessments performed using the FLACC pain scale by a blinded nurse.

Procedures:

CB: 0.125% bupivacaine (1 mL/kg, max 20 mL) injected into the sacral canal under ultrasound guidance.

RLB: 0.25% bupivacaine (0.1 mL/kg) injected into the retrolaminar space at the L4 level under ultrasound guidance.

Postoperative pain will be evaluated at various intervals (30 minutes to 24 hours). Intravenous paracetamol or tramadol will be administered based on pain scores.

The study aims to compare pain scores, time to first analgesic requirement, and postoperative complications, contributing valuable data on these two regional anesthesia techniques in pediatric surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Retrolaminar Block (RLB)

    Procedure/Surgery

    This intervention involves administering 0.25% bupivacaine (0.1 mL/kg) into the retrolaminar space at the L4 vertebral level using a 22-G insulated needle under ultrasound guidance in pediatric patients after induction of general anesthesia.

  • Caudal Block (CB)

    Procedure/Surgery

    This intervention involves administering 0.125% bupivacaine (1 mL/kg, maximum 20 mL) into the sacral canal using a 22-G insulated needle under ultrasound guidance in pediatric patients after induction of general anesthesia.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Retrolaminar block groupExperimental treatment 1 intervention
Group B: Caudal Block (CB) GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Postoperative Pain Scores

Assessment of postoperative pain scores using the FLACC scale (Face, Legs, Activity, Cry, Consolability) at predefined intervals (30 minutes, 1, 2, 4, 6, 12, and 24 hours postoperatively). Scores range from 0 to 10, with higher scores indicating greater pain intensity.

Time frame
Up to 24 hours postoperatively.

Secondary outcomes

1

Time to First Analgesic Requirement

The time elapsed from the completion of the surgical procedure to the first administration of rescue analgesia (IV paracetamol or tramadol) based on FLACC scores.

Time frame
Up to 24 hours postoperatively.
2

Total Analgesic Consumption

The cumulative amount of analgesic medications (paracetamol and/or tramadol) administered within the first 24 hours postoperatively.

Time frame
Up to 24 hours postoperatively.
3

Incidence of Postoperative Complications

The occurrence of complications such as nausea, vomiting, or urinary retention associated with the analgesic techniques used.

Time frame
Up to 24 hours postoperatively.

Other outcomes

Sponsors and contacts

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