Caudal Block vs Retrolaminar Block on Analgesic Consumption in Undescended Testis Surgeries
NCT06725862 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2025-02-18
Summary
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.
Conditions
- Post Operative Pain
Interventions
- PROCEDURE
-
Retrolaminar Block (RLB)
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.
- PROCEDURE
-
Caudal Block (CB)
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.
Sponsors & Collaborators
-
Kanuni Sultan Suleyman Training and Research Hospital
lead OTHER
Principal Investigators
-
Engin ihsan Turan · Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 1 Year
- Max Age
- 7 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-12-15
- Primary Completion
- 2025-12-15
- Completion
- 2025-12-16
Countries
- Turkey (Türkiye)
Study Locations
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