Skip to main content
OpenTrials
Completed

NCT Number: NCT02768493

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Orchiopexy Diverticulectomy Fistula Repair Hydrocelectomy Inguinal Hernioplasty Penoplasty

Age range

6 month–4 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine

Seoul, 120-752, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

1.0 ml/kg of 0.15% ropivacaine

Drug

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

Drug

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.

Primary outcomes

  1. The difference in the optic nerve sheath diameter between groups

    Time frame: 1 day

Secondary outcomes

  1. The variation in the optic nerve sheath diameter before and after caudal block

    Time frame: 30 minutes

  2. the difference in the variation of the optic nerve sheath diameter between groups

    Time frame: 30 minutes

Sponsors and collaborators

Lead sponsor

Yonsei University

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 11, 2016
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.