跳至主要内容
临床试验/NCT03283865
NCT03283865撤回不适用

Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children

Baylor College of Medicine2 个研究点 分布在 1 个国家开始时间: 2017年6月30日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Identify the rate at which blindly placed caudal blocks are not within the epidural space

研究概览

简要总结

Caudal blocks are one of the most commonly performed regional anesthetics in children and are performed daily for a host of infra-umbilical surgical procedures. A caudal block is an epidural injection, most commonly of local anesthetic into the epidural space as accessed via the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which the epidural space may be accessed with extremely minimal risk; as neural tissue ends more proximally. Due to this measure of safety, caudal blocks are preferred in children when compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation and tactile feedback to assess if the medication is being administered in the correct location. As a result of blind injection, administration of local anesthetic totally or partially outside of the correct site can often be unnoticed or identified after a significant volume has already been injected. With the potential for toxicity of local anesthetic, this may result in either the inability to give a complete dose or an unintentional and often unnoticed sham block "incorrect site of injection".

详细描述

Caudal blocks are one of the most commonly performed regional anesthetics in children and are performed daily for a host of infra-umbilical surgical procedures. A caudal block is an epidural injection, most commonly of local anesthetic into the epidural space as accessed via the sacral hiatus. In children, the sacral hiatus is a normally occurring aperture in which the epidural space may be accessed with extremely minimal risk; as neural tissue ends more proximally. Due to this measure of safety, caudal blocks are preferred in children when compared with standard lumbar epidurals. Caudal blocks are performed blindly using palpation and tactile feedback to assess if the medication is being administered in the correct location. As a result of blind injection, administration of local anesthetic totally or partially outside of the correct site can often be unnoticed or identified after a significant volume has already been injected. With the potential for toxicity of local anesthetic, this may result in either the inability to give a complete dose or an unintentional and often unnoticed sham block "incorrect site of injection".

Use of ultrasound has been proposed for identification of caudal block placement and correct medication spread. However, a recent review of the Pediatric Regional Anesthesia Network database reveals that ultrasound is reportedly only used in less that 3% of blocks. The benefit of ultrasound is safe and real-time confirmation of injection. Ultrasound allows the provider to determine with minimal local anesthetic or even saline injection if the correct space is accessed. Without ultrasound, failed blocks are either identified after significant percentage of the total dose of local anesthetic is incorrectly administered or intra or post operatively when the patient demonstrates a significant opioid requirement. This is problematic given that one of the primary benefits of a caudal block in children is the ability to avoid opioids.

Review of local practice here at Texas Children's Hospital for quality improvement purposes revealed a failure rate of caudal blocks to be 18%. Failure was defined as a heart rate increase with incision of >20% despite a caudal block and >1MAC of gas for the patient age. These patients all required opioids both intra and post operatively in addition to surgical levels of inhaled anesthetic agent.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

盲法说明

Single blinded prospective trial in which all patients serve as their own clinical control group.

Provider doing the procedure will be blinded to intervention

入排标准

年龄范围
— 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 0-84 months
  • Infra-umbilical procedure for which a caudal block is already planned
  • American Society of Anesthesiology classifications of 1,2 or 3

排除标准

  • Incarcerated hernias
  • Emergency procedures
  • Local Anesthetic allergy
  • Sacral dimple
  • Rash over sacrum
  • Parents/legal guardians unable to consent for surgical procedure in English language Foster Care/Child protective services as guardians
  • Parental Refusal for caudal block or study participation
  • American Society of Anesthesiology classifications other than 1,2 or 3

结局指标

主要结局

Identify the rate at which blindly placed caudal blocks are not within the epidural space

时间窗: 15 minutes

Assess the percentage of providers not recognizing wrong site of injection without ultrasound

次要结局

  • Identify if lack of heart rate change on incision can predict successful placement when medication administration is successfully confirmed with ultrasound(15 minutes)
  • Identify the rate at which ultrasound can guide a wrong block into the correct location(15 minutes)
  • Identify if after using ultrasound to visualize placement, if concentrations of inhaled agents may be reduced in children(30 minutes to 3 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adam Adler MD, MS, FAAP

Assistant Professor

Baylor College of Medicine

研究点 (2)

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