Clinical trial NCT02768493: Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orchiopexy
Inguinal Hernioplasty
Hydrocelectomy
Diverticulectomy
Fistula Repair
Penoplasty
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-05-11
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.


Eligibility criteria: Inclusion Criteria:

* Pediatric patients
* weighing less than 16 kg
* who receive caudal block before urologic surgery

Exclusion Criteria:

* Subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure
* ophthalmic disease
* expected operation time is less than 30 minutes
* both parents are unable to communicate or speak Korean.

Primary outcomes:
measure: The difference in the optic nerve sheath diameter between groups
timeFrame: 1 day
Secondary outcomes:
measure: The variation in the optic nerve sheath diameter before and after caudal block
timeFrame: 30 minutes
measure: the difference in the variation of the optic nerve sheath diameter between groups
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine
Study officials:
References:
citation: Girisgin AS, Kalkan E, Kocak S, Cander B, Gul M, Semiz M. The role of optic nerve ultrasonography in the diagnosis of elevated intracranial pressure. Emerg Med J. 2007 Apr;24(4):251-4. doi: 10.1136/emj.2006.040931.
citation: Dubourg J, Javouhey E, Geeraerts T, Messerer M, Kassai B. Ultrasonography of optic nerve sheath diameter for detection of raised intracranial pressure: a systematic review and meta-analysis. Intensive Care Med. 2011 Jul;37(7):1059-68. doi: 10.1007/s00134-011-2224-2. Epub 2011 Apr 20.
citation: Dubost C, Le Gouez A, Jouffroy V, Roger-Christoph S, Benhamou D, Mercier FJ, Geeraerts T. Optic nerve sheath diameter used as ultrasonographic assessment of the incidence of raised intracranial pressure in preeclampsia: a pilot study. Anesthesiology. 2012 May;116(5):1066-71. doi: 10.1097/ALN.0b013e318246ea1a.
citation: Lundblad M, Forestier J, Marhofer D, Eksborg S, Winberg P, Lonnqvist PA. Reduction of cerebral mean blood flow velocity and oxygenation after high-volume (1.5 ml kg(-)(1)) caudal block in infants. Br J Anaesth. 2014 Oct;113(4):688-94. doi: 10.1093/bja/aeu161. Epub 2014 Jun 27.
citation: Lee B, Koo BN, Choi YS, Kil HK, Kim MS, Lee JH. Effect of caudal block using different volumes of local anaesthetic on optic nerve sheath diameter in children: a prospective, randomized trial. Br J Anaesth. 2017 May 1;118(5):781-787. doi: 10.1093/bja/aex078.