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Clinical Trials/NCT04491032
NCT04491032
Completed
Not Applicable

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

Aybike Onur Gönen1 site in 1 country58 target enrollmentFebruary 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia, Caudal
Sponsor
Aybike Onur Gönen
Enrollment
58
Locations
1
Primary Endpoint
Change in optic nerve sheath diameter
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
February 15, 2019
End Date
March 15, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Aybike Onur Gönen
Responsible Party
Sponsor Investigator
Principal Investigator

Aybike Onur Gönen

Resident in Anesthesiology and Intensive Care

Istanbul University

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

  • Variation in optic nerve sheath diameter(From before caudal injection to immediately, 10 min, 20 min and 30 min after.)
  • Variation in cerebral oxygenation(From before caudal injection to immediately, 10 min, 20 min and 30 min after.)

Study Sites (1)

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