Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block

Inguinal Hernioplasty Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02768493
• Other study ID #: 4-2016-0192
• Status: Completed
• Phase: N/A
• First received: May 8, 2016
• Last updated: September 7, 2016
• Start date: May 2016
• Est. completion date: August 2016

Study information

• Verified date: September 2016
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 4 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Diverticulectomy
• Fistula
• Fistula Repair
• Hydrocelectomy
• Inguinal Hernioplasty
• Orchiopexy
• Penoplasty

Intervention

Drug:
• 1.0 ml/kg of 0.15% ropivacaine
Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.
• 1.5 ml/kg of 0.15% ropivacaine
Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.

Locations

Country	Name	City	State
Korea, Republic of	Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. Review. — View 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. — View Citation

Lundblad M, Forestier J, Marhofer D, Eksborg S, Winberg P, Lönnqvist 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the optic nerve sheath diameter between groups		1 day	Yes
Secondary	The variation in the optic nerve sheath diameter before and after caudal block		30 minutes	Yes
Secondary	the difference in the variation of the optic nerve sheath diameter between groups		30 minutes	Yes