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

NCT ID: NCT01340313

Last Updated: 2013-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-03-31

Study Completion Date

2011-08-31

Brief Summary

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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

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Conditions

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Children Who Need Urological Surgery

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

4 times evaluation according to doses in 1 group

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hae Kum Kil, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Severance Hospital

Locations

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Hae Keum Kil

Seoul, Seoul, South Korea

Site Status

Countries

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South Korea

References

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Hong JY, Han SW, Kim WO, Cho JS, Kil HK. A comparison of high volume/low concentration and low volume/high concentration ropivacaine in caudal analgesia for pediatric orchiopexy. Anesth Analg. 2009 Oct;109(4):1073-8. doi: 10.1213/ane.0b013e3181b20c52.

Reference Type BACKGROUND
PMID: 19762734 (View on PubMed)

Shin SK, Hong JY, Kim WO, Koo BN, Kim JE, Kil HK. Ultrasound evaluation of the sacral area and comparison of sacral interspinous and hiatal approach for caudal block in children. Anesthesiology. 2009 Nov;111(5):1135-40. doi: 10.1097/ALN.0b013e3181bc6dd4.

Reference Type BACKGROUND
PMID: 19809281 (View on PubMed)

Koo BN, Hong JY, Kil HK. Spread of ropivacaine by a weight-based formula in a pediatric caudal block: a fluoroscopic examination. Acta Anaesthesiol Scand. 2010 May;54(5):562-5. doi: 10.1111/j.1399-6576.2010.02224.x. Epub 2010 Mar 10.

Reference Type BACKGROUND
PMID: 20236099 (View on PubMed)

Lundblad M, Lonnqvist PA, Eksborg S, Marhofer P. Segmental distribution of high-volume caudal anesthesia in neonates, infants, and toddlers as assessed by ultrasonography. Paediatr Anaesth. 2011 Feb;21(2):121-7. doi: 10.1111/j.1460-9592.2010.03485.x. Epub 2010 Dec 15.

Reference Type BACKGROUND
PMID: 21159024 (View on PubMed)

Other Identifiers

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4-2010-0775

Identifier Type: -

Identifier Source: org_study_id

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