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

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.

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Key information

Conditions

Children Who Need Urological Surgery

Age range

3 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hae Keum Kil

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

drug spread level with a weight-based doses

Time frame: every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).
- spread levels of drug within the epidural space during drug injection with caudal block at every doses using real-time ultrasound examination.
- maximum spread levels within the epidural space

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Apr 22, 2011
Registry last updated: Mar 6, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.