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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04491032
Other study ID # 72109855-604.01.01-10728
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2019
Est. completion date March 15, 2022

Study information

Verified date June 2022
Source Istanbul University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 58
Est. completion date March 15, 2022
Est. primary completion date March 15, 2022
Accepts healthy volunteers No
Gender All
Age group 12 Months to 8 Years
Eligibility 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

Study Design


Intervention

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

Locations

Country Name City State
Turkey Istanbul University Cerrahpasa Istanbul

Sponsors (6)

Lead Sponsor Collaborator
Aybike Onur Gönen Ayse Cigdem Tutuncu, Guner Kaya, Pinar Kendigelen, Rahsan Ozcan, Senol Emre

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in hemodynamic and respiratory parameters Mean arterial pressure, heart rate, end-tidal carbondioxide pressure, peak inspiratory pressure, peripheral oxygen saturation, oxygen fraction of inhaled gas From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Primary Change in optic nerve sheath diameter Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Primary Change in cerebral oxygenation Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Secondary Variation in optic nerve sheath diameter Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter in each group From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Secondary Variation in cerebral oxygenation Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation in each group From before caudal injection to immediately, 10 min, 20 min and 30 min after.
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