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Clinical Trials/NCT01340313
NCT01340313
Completed
Not Applicable

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

Yonsei University1 site in 1 country72 target enrollmentMarch 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Children Who Need Urological Surgery
Sponsor
Yonsei University
Enrollment
72
Locations
1
Primary Endpoint
drug spread level with a weight-based doses
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
August 2011
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • children who needed caudal block for postoperative analgesia (age 3 months \~ 5 years old)
  • Consent from one of parents
  • 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

Outcomes

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).

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

Study Sites (1)

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