Clinical trial NCT01340313: Ultrasonographic Evaluation of Drug Spread in Epidural Space During Caudal Block in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children Who Need Urological Surgery
Keywords: caudal block, children, ultrasound, urological surgery
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2011-04-22
Enrollment: 72
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 3 months old \~ 5 years old children undergoing minor infra-umbilical 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.


Eligibility criteria: 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

Primary outcomes:
measure: drug spread level with a weight-based doses
timeFrame: every 10 seconds for 1 minute during drug injection (10, 20, 30, 40, 50, and 60 seconds).
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hae Keum Kil
Study officials:
affiliation: Severance Hospital
name: Hae Kum Kil, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.