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临床试验/NCT06319989
NCT06319989已完成不适用

The Efficacy of Biplane Versus Single Plane Ultrasound in Facilitating Caudal Epidural Anesthesia in Pediatric Patients.

University of Florida2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2024年8月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
46
试验地点
2
主要终点
First puncture success

研究概览

简要总结

Ultrasound guidance plays a pivotal role in caudal epidural block in pediatric patients. In comparison to conventional single-plane ultrasound, biplane ultrasound offers the advantage of providing simultaneous transverse and longitudinal imaging. Better visualization under biplane ultrasound is postulated to enhance the efficacy of caudal epidural blocks. This improvement is expected to manifest through higher first puncture success rate, shorter procedure time, and longer time to first postoperative analgesics use.

详细描述

Our study aims to recruit pediatric patients receiving caudal epidural blocks as a complement to general anesthesia and for postoperative analgesia. Through a randomized allocation, we will administer the caudal injection with either a biplane ultrasound-guided approach or the single-plane ultrasound-guided technique. The assessment will encompass accuracy metrics, such as the first puncture success rate and number of needle redirections, and the efficiency indicators, including the time from initial probe placement on the skin to successful injection, the time to first postoperative analgesics use, and PACU (post anesthesia care unit) pain score. Safety evaluation will be conducted, encompassing adverse events from the commencement of the caudal block procedure until discharge. We will also conduct post-discharge follow-up phone calls to evaluate patients' experience after discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

盲法说明

The intervention group will receive caudal epidural block under the guidance of biplane ultrasound. The procedures for patients in the control group will be guided by conventional single-plane ultrasound.

入排标准

年龄范围
4 Months 至 10 Years(Child)
性别
Male
接受健康志愿者

入选标准

  • ASA I/II (Anesthesia Physical Status Classification System)
  • Male patients aged 4 months to 10 years
  • To undergo elective circumcision with caudal epidural anesthesia as an adjuvant to general anesthesia and for postoperative analgesia

排除标准

  • Anatomical anomalies (e.g., tethered cord, sacral malformations, etc.).
  • Potential coagulopathy.
  • Preoperative analgesics use.
  • Allergy to local anesthetics.
  • Rash or infection at the injection site.
  • Female patients
  • Parents refuse to participate.

研究组 & 干预措施

Biplane Ultrasound

Other

The intervention group will receive caudal epidural block under the guidance of biplane ultrasound.

干预措施: Biplane Ultrasound (Other)

Single plane Ultrasound

Other

The procedures for patients in the control group will be guided by conventional single-plane ultrasound.

干预措施: Single plane ultrasound (Other)

结局指标

主要结局

First puncture success

时间窗: 1 day

The epidural is obtained on first attempt.

次要结局

  • Postoperative analgesic use(24 hours post-op)
  • Duration of epidural(1 day)
  • Number of Needle redirections(1day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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