Clinical trial NCT04491032: Pediatric Caudal Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation
Official title: The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia, Caudal
Pediatrics
Elevated Intracranial Pressure
Keywords: optic nerve sheath diameter
cerebral oximetry
caudal epidural anesthesia
Lead sponsor: Istanbul University
Sponsor class: OTHER
Collaborators: name: Pinar Kendigelen
name: Ayse Cigdem Tutuncu
name: Kaya, Guner, M.D.
name: Senol Emre
name: Rahsan Ozcan
First posted: 2020-07-29
Enrollment: 58
Sex: ALL
Minimum age (years): 12
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will receive either a low or high volume of caudal injection.
Primary purpose: SCREENING

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in optic nerve sheath diameter
timeFrame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
measure: Change in cerebral oxygenation
timeFrame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Secondary outcomes:
measure: Variation in optic nerve sheath diameter
timeFrame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
measure: Variation in cerebral oxygenation
timeFrame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Other outcomes:
measure: Changes in hemodynamic and respiratory parameters
timeFrame: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Aybike Onur Gönen, MD
role: STUDY_DIRECTOR
References: