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

Primary Purpose

Orchiopexy, Inguinal Hernioplasty, Hydrocelectomy

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
1.0 ml/kg of 0.15% ropivacaine
1.5 ml/kg of 0.15% ropivacaine
Sponsored by
Yonsei University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Orchiopexy

Eligibility Criteria

6 Months - 4 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

low dose group

high dose group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The difference in the optic nerve sheath diameter between groups

Secondary Outcome Measures

The variation in the optic nerve sheath diameter before and after caudal block
the difference in the variation of the optic nerve sheath diameter between groups

Full Information

First Posted
May 8, 2016
Last Updated
September 7, 2016
Sponsor
Yonsei University
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1. Study Identification

Unique Protocol Identification Number
NCT02768493
Brief Title
Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orchiopexy, Inguinal Hernioplasty, Hydrocelectomy, Diverticulectomy, Fistula Repair, Penoplasty

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
low dose group
Arm Type
Experimental
Arm Description
Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.
Arm Title
high dose group
Arm Type
Active Comparator
Arm Description
Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.
Intervention Type
Drug
Intervention Name(s)
1.0 ml/kg of 0.15% ropivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
1.5 ml/kg of 0.15% ropivacaine
Intervention Description
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 Outcome Measure Information:
Title
The difference in the optic nerve sheath diameter between groups
Time Frame
1 day
Secondary Outcome Measure Information:
Title
The variation in the optic nerve sheath diameter before and after caudal block
Time Frame
30 minutes
Title
the difference in the variation of the optic nerve sheath diameter between groups
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei universiy college of medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17384377
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.
Results Reference
background
PubMed Identifier
21505900
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.
Results Reference
background
PubMed Identifier
22258019
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.
Results Reference
background
PubMed Identifier
24972788
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.
Results Reference
background
PubMed Identifier
28486629
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.
Results Reference
derived

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

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