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

Not Applicable

Completed

• Conditions: Orchiopexy; Inguinal Hernioplasty; Hydrocelectomy; Diverticulectomy; Fistula Repair; Penoplasty
• Interventions: Drug: 1.0 ml/kg of 0.15% ropivacaine; Drug: 1.5 ml/kg of 0.15% ropivacaine

• Registration Number: NCT02768493
• Lead Sponsor: Yonsei University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-08
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-11
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-07
• Last Update Posted: 2016-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
low dose group	1.0 ml/kg of 0.15% ropivacaine	Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.
high dose group	1.5 ml/kg of 0.15% ropivacaine	Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.

Primary Outcome Measures

Name	Time	Method
The difference in the optic nerve sheath diameter between groups	1 day

Secondary Outcome Measures

Name	Time	Method
The variation in the optic nerve sheath diameter before and after caudal block	30 minutes
the difference in the variation of the optic nerve sheath diameter between groups	30 minutes

Trial Locations

Locations (1)

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine; 🇰🇷 Seoul, Korea, Republic of