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

NCT06725862 | Recruiting

• 1 other identifier: caudal vs retrolaminar
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Post Operative Pain

Outcome Measures

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.

  Up to 24 hours postoperatively.

Secondary Outcomes (3)

• Time to First Analgesic Requirement

  Up to 24 hours postoperatively.

• Total Analgesic Consumption

  Up to 24 hours postoperatively.

• Incidence of Postoperative Complications

  Up to 24 hours postoperatively.

Study Arms (2)

Retrolaminar block group

EXPERIMENTAL

Pediatric patients in this group will receive a retrolaminar block (RLB) using 0.25% bupivacaine (0.1 mL/kg) injected into the retrolaminar space at the L4 vertebral level under ultrasound guidance after general anesthesia induction.

Procedure: Retrolaminar Block (RLB)

Caudal Block (CB) Group

ACTIVE COMPARATOR

Pediatric patients in this group will receive a caudal block (CB) using 0.125% bupivacaine (1 mL/kg, maximum 20 mL) injected into the sacral canal under ultrasound guidance after general anesthesia induction.

Procedure: Caudal Block (CB)

Interventions

Retrolaminar Block (RLB) PROCEDURE

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.

Retrolaminar block group

Caudal Block (CB) PROCEDURE

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.

Caudal Block (CB) Group

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital: lead

Study Sites (2)

Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

Istanbul, 34303, Turkey (Türkiye)

RECRUITING

Zincirlikuyu Medicana Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Engin ihsan Turan

  Health Science University İstanbul Kanuni Sultan Süleyman Education and Training Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engin ihsan Turan

CONTACT

05382431114; enginihsan@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: anesthesiology and reanimation specialist

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 10, 2024
• Study Start: December 15, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 16, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Locations

TU (2)