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

Pediatrics Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04491032
• Other study ID #: 72109855-604.01.01-10728
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anesthesia, Caudal
• Elevated Intracranial Pressure
• Intracranial Hypertension
• Pediatrics

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.