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

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

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.

Study Overview

• Status: Completed
• Conditions: Pediatrics; Anesthesia, Caudal; Elevated Intracranial Pressure
• Intervention / Treatment: Procedure: Caudal anesthesia

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34098
    • Istanbul University Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 8 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Low Volume; Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution	Procedure: Caudal anesthesia; Caudal epidural injection will be performed after induction of general anesthesia.
ACTIVE_COMPARATOR: High Volume; Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution	Procedure: Caudal anesthesia; Caudal epidural injection will be performed after induction of general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Aybike Onur Gonen
• Collaborators: Ayse Cigdem Tutuncu; Senol Emre; Kaya, Guner, M.D.; Pinar Kendigelen; Rahsan Ozcan
• Investigators: Study Director: Aybike Onur Gönen, MD, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 15, 2019
• Primary Completion (ACTUAL): March 15, 2022
• Study Completion (ACTUAL): March 15, 2022

Study Registration Dates

• First Submitted: July 27, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (ACTUAL): July 29, 2020

Study Record Updates

• Last Update Posted (ACTUAL): June 30, 2022
• Last Update Submitted That Met QC Criteria: June 29, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: cerebral oximetry; optic nerve sheath diameter; caudal epidural anesthesia
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 72109855-604.01.01-10728

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No formal plans to share IPD is made

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No