RecruitingNot ApplicableNCT06725862

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

Comparison of the Effects of Caudal Block and Retrolaminar Block on Analgesic Consumption in Postoperative Pain Management for Pediatric Undescended Testis Surgeries


Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Enrollment

60 participants

Start Date

Dec 15, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 1 YearMax Age: 7 Years

Inclusion Criteria1

  • Pediatric patients aged 1-7 years. ASA (American Society of Anesthesiologists) physical status I or II. Scheduled for unilateral undescended testis surgery. Parental/guardian consent provided for study participation.

Exclusion Criteria1

  • Age under 1 year or over 7 years. Neurological deficits. Coagulopathy or bleeding disorders. History of allergy to local anesthetics. Signs of redness, infection, or other abnormalities at the injection site. Congenital spinal anomalies. Intellectual disability or psychiatric disorders. Hepatic or renal impairment. Refusal to participate in the study by parents or guardians.

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Interventions

PROCEDURERetrolaminar 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.

PROCEDURECaudal 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.


Locations(2)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, Turkey (Türkiye)

Zincirlikuyu Medicana Hospital

Istanbul, Turkey (Türkiye)

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NCT06725862


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