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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 1
SponsorIstanbul University - Cerrahpasa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Participants will be recruited from infants scheduled for elective surgical procedures at the operating rooms of the Department of Anesthesiology and Reanimation, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa. The study population consists of infants undergoing routine perioperative evaluation under general anesthesia in a tertiary academic medical center.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Ultrasonographic Assessment of Skin-to-Epidural Distance

    Diagnostic test

    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

    Procedure/Surgery

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Infants Ungergoing Elective Surgery2 interventions

Trial outcomes

Primary outcomes

1

Ultrasonographic Skin-to-Epidural Distance

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.

Time frame
During perioperative ultrasonographic assessment immediately after induction of general anesthesia

Secondary outcomes

1

Comparison of Parasagittal Oblique and Transverse Median Ultrasound Measurements

Comparison of skin-to-epidural distance measurements obtained in the paramedian sagittal oblique and transverse median ultrasound planes.

Time frame
During perioperative ultrasonographic assessment immediately after induction of general anesthesia
2

Intraobserver and Interobserver Measurement Reliability

Assessment of consistency of repeated ultrasonographic skin-to-epidural distance measurements performed by experienced anesthesiologists.

Time frame
During perioperative ultrasonographic assessment immediately after induction of general anesthesia
3

Agreement Between Ultrasonographic Measurements and Epidural Needle Depth

Agreement between ultrasonographically measured skin-to-epidural distance and clinically measured epidural needle depth in participants undergoing epidural analgesia for routine clinical indications.

Time frame
During epidural analgesia procedure performed as part of routine perioperative care

Other outcomes

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