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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-15

Study Completion Date

2022-03-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Anesthesia, Caudal Pediatrics Elevated Intracranial Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will receive either a low or high volume of caudal injection.

Primary Study Purpose

SCREENING

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Investigator, who will take and record the measurements, will not know about the volume of caudal injection. Another investigator will analyze the ultrasonography images without any knowledge of the patient or the intervention.

Study Groups

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Low Volume

Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution

Group Type ACTIVE_COMPARATOR

Caudal anesthesia

Intervention Type PROCEDURE

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

High Volume

Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution

Group Type ACTIVE_COMPARATOR

Caudal anesthesia

Intervention Type PROCEDURE

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

Interventions

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Caudal anesthesia

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

12 Months

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No