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

Aybike Onur Gönen

Status: Completed

Conditions: Anesthesia, Caudal; Pediatrics; Elevated Intracranial Pressure

Treatments: Procedure: Caudal anesthesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04491032

72109855-604.01.01-10728

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Ages: 12 months to 8 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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58 participants in 2 patient groups

Low Volume

Active Comparator group

Description:

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

Treatment:

Procedure: Caudal anesthesia

High Volume

Active Comparator group

Description:

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

Treatment:

Procedure: Caudal anesthesia