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NCT Number: NCT04491032

Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation

Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a certain volume of fluid into the epidural space for cauda anesthesia may push some cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the head. Such mild changes are compensated well by healthy individuals and no clinical sequel is seen, however at-risk populations may be affected. We aim to see how different amounts of fluid injected into the epidural space may change two clinical parameters affected by intracranial pressure to determine if a lower volume is safer than a higher one.

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Key information

Conditions

Anesthesia, Caudal Brain Diseases Central Nervous System Diseases Elevated Intracranial Pressure Intracranial Hypertension Nervous System Diseases Pediatrics

Age range

12 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University Cerrahpasa

Istanbul, 34098, Turkey (Türkiye)

About this study

Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus allows for easy and safe access into the epidural space. Anatomically, injection of a certain volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal fluid cranially. This push may lead to increased intracranial pressure. We will measure two findings affected by intracranial pressure (optic nerve sheath diameter and cerebral oxygenation) and compare the effects of two different volumes of caudal injections on these measures.

Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal anesthesia is an effective method for peri-operative analgesia, will be recruited for this study. Injection volume will be determined depending on the level of analgesia required for the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after caudal anesthesia.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ASA class 1 or 2
  • Scheduled for elective surgery suitable for caudal anesthesia
  • Parental/guardian consent for caudal anesthesia and measurements obtained
  • Closed fontanelles

Exclusion criteria

  • Open fontanelle
  • Parental/guardian refusal
  • Previous intracranial or ocular pathology
  • Coagulapathies
  • Variations in gross and ultrasonographic sacral anatomy
  • Block performence to end of surgery expected to last less than 30 minutes
  • Block volumes more than 30ml needed
  • Laparoscopic surgery
  • Need for long term analgesia with epidural catheter

Treatment and study plan

Caudal anesthesia

Procedure

Caudal epidural injection will be performed after induction of general anesthesia.

Primary outcomes

  1. Change in optic nerve sheath diameter

    Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.

    Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups

  2. Change in cerebral oxygenation

    Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.

    Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups

Secondary outcomes

  1. Variation in optic nerve sheath diameter

    Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.

    Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group

  2. Variation in cerebral oxygenation

    Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.

    Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group

Other outcomes

  1. Changes in hemodynamic and respiratory parameters

    Time frame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.

    Mean arterial pressure, heart rate, end-tidal carbondioxide pressure, peak inspiratory pressure, peripheral oxygen saturation, oxygen fraction of inhaled gas

Sponsors and collaborators

Lead sponsor

Aybike Onur Gönen

Other

Collaborators

  • Ayse Cigdem Tutuncu
  • Kaya, Guner, M.D.
  • Pinar Kendigelen
  • Rahsan Ozcan
  • Senol Emre

Registry information

Official study title

The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2020
Registry last updated
Jun 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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