Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children

Completed

• Conditions: Children Who Need Urological Surgery

• Registration Number: NCT01340313
• Lead Sponsor: Yonsei University

Brief Summary

Caudal block is the world-widely used technique for an effective postoperative analgesia in children undergoing OPD-based infra-umbilical surgery. Because the caudal block is usually performed with a single-shot, proper dosage is required to achieve sufficient analgesic levels. Several clinical researches have been performed to assess the drug spread levels using mathematical equation, X-ray evaluation, and ultrasonography during caudal block in children. In our previous study using fluoroscopy, we obtained the results that the established weight-based doses provided adequate block levels for each type of surgery.

Ultrasonography is precise tool to evaluate the spinal structures and can provide estimated information in real time during caudal or epidural block in children.

The aim of this study is to evaluate the drug spread level with a weight-based doses using ultrasonography during caudal block in children and assess the reliability of the real time ultrasonography to determine the drug spread levels. After general anesthesia, the patient will be placed in lateral decubitus position for caudal block. Total 1.5 ml/kg of 0.15% ropivacaine will be injected into the caudal space. The spread level will be step-wise evaluated using ultrasonography at the injected drug dose of 0.5 ml/kg, 1.0 ml/kg, 1.25 ml/kg, and 1.5 ml/kg.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-05
• Study First Submitted QC: 2011-04-19
• Study First Posted: 2011-04-22
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-04
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• children who needed caudal block for postoperative analgesia (age 3 months ~ 5 years old)
• Consent from one of parents 3. ASA physical status I or II

Exclusion Criteria

• bleeding tendency
• spinal anomaly
• infection focus on back
• allergic reaction to local anesthetics
• foreigner of illiteracy who cannot read consent form

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
drug spread level with a weight-based doses	every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).	1. spread levels of drug within the epidural space during drug injection with caudal block at every doses using real-time ultrasound examination.; 2. maximum spread levels within the epidural space

Trial Locations

Locations (1)

Hae Keum Kil; 🇰🇷 Seoul, Korea, Republic of