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 volunteersQualifiers
None
Disqualifiers
None
Trial design
Parallel
Treatments tested in this trial
Retrolaminar Block (RLB)
Procedure/SurgeryThis 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/SurgeryThis 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
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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.
Total Analgesic Consumption
The cumulative amount of analgesic medications (paracetamol and/or tramadol) administered within the first 24 hours postoperatively.
Incidence of Postoperative Complications
The occurrence of complications such as nausea, vomiting, or urinary retention associated with the analgesic techniques used.
Sponsors and contacts
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