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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01340313
Enrollment
72
Registered
2011-04-22
Start date
2011-03-31
Completion date
2011-08-31
Last updated
2013-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Children Who Need Urological Surgery

Keywords

caudal block, children, ultrasound, urological surgery

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.

Interventions

None listed

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Months to 5 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
drug spread level with a weight-based dosesevery 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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026