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

Condition(s) studied

Investigational drug(s) / intervention(s)

Ultrasonographic Assessment of Skin-to-Epidural Distance: Infants aged 0 to 12 months undergoing elective surgery under general anesthesia will undergo ultrasonographic assessment of the distance between the skin and the epidural space. Measurements will be performed in the lateral decubitus position using a high-frequency linear ultrasound transducer with minimal probe pressure to avoid soft tissue compression. The distance will be evaluated at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, the first and second lumbar vertebrae, the second and third lumbar vertebrae, and the third and fourth lumbar vertebrae. Measurements will be obtained using both the paramedian sagittal oblique and transverse median ultrasound views. Two experienced anesthesiologists will independently perform the measurements. The probe will be removed and repositioned before repeat measurements. No needle insertion or epidural catheter placement will be performed as part of this intervention.

Epidural Catheter Placement for Clinical Indications: A subgroup of infants requiring epidural analgesia as part of routine perioperative care will undergo epidural catheter placement. Epidural catheterization will not be performed for research purposes and will only be undertaken when clinically indicated. Following ultrasonographic assessment and induction of general anesthesia, infants will be positioned in the lateral decubitus position. Epidural catheter placement will be performed according to standard institutional practice. The epidural space will be identified using the loss-of-resistance technique at the vertebral level selected by the attending anesthesiologist, and the depth from the skin to the epidural space will be recorded. Catheter insertion, confirmation of placement, and analgesic management will follow routine clinical protocols. Data from these procedures will be used to compare actual epidural depth with ultrasonographic measurements. No additional invasive procedures will be performed for study purposes.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Ultrasonographic Skin-to-Epidural Distance — 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.

Trial sites (1)

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