NCT06725862 Caudal Block vs Retrolaminar Block on Analgesic Consumption in Undescended Testis Surgeries
| NCT ID | NCT06725862 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kanuni Sultan Suleyman Training and Research Hospital |
| Condition | Post Operative Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-12-15 |
| Primary Completion | 2025-12-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-12-15 with a primary completion date of 2025-12-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 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 Criteria: 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.
Contact & Investigator
Engin ihsan Turan
PRINCIPAL INVESTIGATOR
Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital
Frequently Asked Questions
Who can join the NCT06725862 clinical trial?
This trial is open to male participants only, aged 1 Year or older, up to 7 Years, studying Post Operative Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06725862 currently recruiting?
Yes, NCT06725862 is actively recruiting participants. Contact the research team at enginihsan@hotmail.com for enrollment information.
Where is the NCT06725862 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye), Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT06725862 clinical trial?
NCT06725862 is sponsored by Kanuni Sultan Suleyman Training and Research Hospital. The principal investigator is Engin ihsan Turan at Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital. The trial plans to enroll 60 participants.