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临床试验/NCT07847762
NCT07847762尚未招募不适用

Evaluation of Skin-to-Epidural Distance With Ultrasonography at Different Vertebral Levels in Infants: A Prospective Observational Study

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Ultrasonographic Skin-to-Epidural Distance

研究概览

简要总结

The goal of this observational study is to learn about the distance between the skin and the epidural space in infants younger than 12 months. The epidural space is an area near the spinal cord where doctors can give pain medicine to help control pain during and after surgery. Epidural pain treatment can greatly reduce the amount of pain a child feels after surgery. Researchers will use ultrasound, a method that uses sound waves to create images inside the body and does not have harmful effects on the body, to measure this distance in babies having planned surgery under general anesthesia. General anesthesia is a medicine that keeps patients asleep during surgery.

The main questions this study aims to answer are: Does the distance between the skin and the epidural space change with a baby's age, weight, height, or gestational age? Are the measurements similar when ultrasound images are taken from different directions? How close are the ultrasound measurements to the actual depth reached by the needle in babies who receive epidural pain treatment as part of their regular medical care?

Participants will have ultrasound images taken after they are asleep under general anesthesia. Measurements will be taken at 4 different areas of the lower back and from 2 different viewing directions. The measurements will be performed by 2 experienced doctors. Each doctor will repeat the same measurements 2 times to check consistency. Participants will receive epidural pain treatment only if it is already planned as part of their usual care.

No extra invasive procedure or additional medication will be given for this study.

详细描述

Epidural analgesia is an effective method for perioperative pain management in pediatric patients and is widely used to reduce postoperative pain and opioid requirements. In infants, however, epidural procedures may be technically challenging because spinal anatomical structures are smaller and continue to change during early development. Variability in vertebral anatomy, ligament thickness, and spinal cord termination level may increase the difficulty of predicting epidural depth during neuraxial procedures. Even small differences in needle depth may be clinically important in this age group.

Ultrasonography has become an increasingly important tool in pediatric regional anesthesia because it provides real-time visualization of spinal anatomy without radiation exposure or harmful effects on the body. Preprocedural ultrasonographic assessment may help identify anatomical landmarks and estimate epidural depth before needle insertion. Previous studies have demonstrated that ultrasound measurements may correlate with actual epidural needle depth in pediatric patients. However, available data regarding normative skin-to-epidural distance measurements in infants remain limited, particularly at different vertebral levels and with different ultrasound imaging planes.

In infants, identification of the epidural space using conventional loss-of-resistance techniques may be more difficult than in older children and adults because tissue resistance changes may be less distinct. In addition, spinal anatomy changes rapidly during infancy, and measurements obtained at one vertebral level may not reflect measurements at other levels. Evaluation of multiple vertebral levels and imaging planes may therefore provide more comprehensive anatomical information for pediatric epidural procedures.

This study is designed to evaluate ultrasonographic skin-to-epidural distance measurements at multiple lumbar and thoracolumbar vertebral levels in infants undergoing elective surgery under general anesthesia. Measurements will be obtained using two commonly used ultrasound imaging planes to better characterize epidural depth in this population. The study will also evaluate the relationship between ultrasonographic measurements and demographic characteristics such as age, body weight, height, and gestational age.

Ultrasonographic evaluations will be performed during routine perioperative preparation under general anesthesia without additional invasive intervention for study purposes. In participants who undergo epidural catheter placement as part of routine clinical management, ultrasonographic measurements will additionally be compared with clinically measured epidural needle depth. Findings from this study may contribute to the development of more reliable reference data for infant epidural procedures and may support safer and more individualized pediatric regional anesthesia practices.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 1 Year(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Infants aged 0 to 12 months
  • •Scheduled for elective surgery under general anesthesia
  • •American Society of Anesthesiologists physical status I to III
  • •Written informed consent obtained from parents or legal guardians

排除标准

  • •Known vertebral or spinal cord anomalies, including scoliosis or spina bifida
  • •Previous spinal surgery
  • •Neuromuscular disease or known spinal cord pathology
  • •Congenital syndromes associated with systemic malformations
  • •Severe pulmonary, cardiac, hemodynamic, or neurological instability
  • •Emergency surgery
  • •Unreliable or incomplete ultrasonographic measurement data due to technical difficulties
  • •Absence of written informed consent from parents or legal guardians

研究组 & 干预措施

Infants Ungergoing Elective Surgery

Infants aged 0-12 months undergoing elective surgery under general anesthesia who will undergo ultrasonographic skin-to-epidural distance measurements during routine perioperative care.

干预措施: Ultrasonographic Assessment of Skin-to-Epidural Distance (Diagnostic Test)

Infants Ungergoing Elective Surgery

Infants aged 0-12 months undergoing elective surgery under general anesthesia who will undergo ultrasonographic skin-to-epidural distance measurements during routine perioperative care.

干预措施: Epidural Catheter Placement for Clinical Indications (Procedure)

结局指标

主要结局

Ultrasonographic Skin-to-Epidural Distance

时间窗: During perioperative ultrasonographic assessment immediately after induction of general anesthesia

Distance between the skin and the epidural space measured by ultrasonography at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, between the first and second lumbar vertebrae, between the second and third lumbar vertebrae, and between the third and fourth lumbar vertebrae in infants.

次要结局

  • Comparison of Parasagittal Oblique and Transverse Median Ultrasound Measurements(During perioperative ultrasonographic assessment immediately after induction of general anesthesia)
  • Intraobserver and Interobserver Measurement Reliability(During perioperative ultrasonographic assessment immediately after induction of general anesthesia)
  • Agreement Between Ultrasonographic Measurements and Epidural Needle Depth(During epidural analgesia procedure performed as part of routine perioperative care)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bahar İnan

Resident Physician, Department of Anesthesiology and Reanimation

Istanbul University - Cerrahpasa

研究点 (1)

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