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Comparison of Caudal Block and Retrolaminar Block for Circumcision

NCT06584292 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-02-19

No results posted yet for this study

Summary

Primary Outcome:

Analgesic Efficiency: The primary outcome is the comparison of the analgesic efficacy of the retrolaminar block (RL) versus caudal block (CB) based on postoperative pain scores measured by the FLACC score. This outcome aims to evaluate how effectively each block controls postoperative pain.

Secondary Outcomes:

Analgesic Requirements:

The amount of analgesic required within the first 24 hours postoperatively. The time to the first analgesic requirement. These will be recorded during postoperative follow-up visits at 30 minutes, 1, 2, 4, 6, 12, and 24 hours by an anesthesiologist who is blinded to the study groups.

Postoperative Complications:

Urinary Retention: Defined as a distended palpable bladder associated with pain.

Motor Block: The presence of lower extremity motor block will be evaluated using the modified Bromage scale (0: No motor block; 1: Able to move the legs; 2: Unable to move the legs).

Ecchymosis and Hematoma: The presence of ecchymosis (discoloration of the skin due to blood infiltration in the subcutaneous tissues) and hematoma (abnormal swelling or hardening caused by the accumulation of blood) at the injection site will be assessed.

Conditions

  • Regional Anesthesia

Interventions

PROCEDURE

caudal block

Caudal Block (CB) Procedure: The sacral hiatus was identified using an out-of-plane transverse ultrasound view at the level of the sacral cornua. The probe was then rotated longitudinally to visualize the sacrococcygeal ligament and sacral bone. A block needle was inserted through the sacrococcygeal membrane into the sacral canal using the in-plane technique, and 0.125% bupivacaine was administered at a dose of 1 mL/kg, with a maximum limit of 20 mL per side.

PROCEDURE

Retrolaminar block

Retrolaminar Block (RL) Procedure: The RL block was performed with the patient in a lateral decubitus position. The ultrasound probe was positioned at the L4 vertebral level in a paramedian sagittal plane. The probe was moved medially until the vertebral laminae were visualized. The needle was inserted using the in-plane technique, advancing from the cephalad to caudal direction until it contacted the L4 lamina. A dose of 0.1 mL/kg of 0.25% bupivacaine was then injected into the retrolaminar space.

Sponsors & Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

    lead OTHER

Principal Investigators

  • Volkan Özen, Associate Proffesor · Health Science University İstanbul Prof Dr Cemil Taşcıoğlu City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-27
Primary Completion
2024-12-15
Completion
2024-12-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06584292 on ClinicalTrials.gov