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OrchiopexyNCT02768493

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

A study testing 1.0 ml/kg of 0.15% ropivacaine and 1.5 ml/kg of 0.15% ropivacaine in people with Orchiopexy and Inguinal Hernioplasty, run by Yonsei University at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 6 months to 4 years
Conditions the study is for
Orchiopexy, Inguinal Hernioplasty, Hydrocelectomy
What is being tested?
1.0 ml/kg of 0.15% ropivacaine and 1.5 ml/kg of 0.15% ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSouth Korea
Study dates
May 2016to Aug 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months to 4 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

South Korea1 site

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

    Seoul, 120-752

Other trials in South Korea

About this study

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.

Being tested
1.0 ml/kg of 0.15% ropivacaine, 1.5 ml/kg of 0.15% ropivacaine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 1.0 ml/kg of 0.15% ropivacaineDrug

    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% ropivacaineDrug

    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.

Study groups in NCT02768493
Study groupRoleWhat they receive
low dose groupExperimentalPatients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.
Receives: Drug: 1.0 ml/kg of 0.15% ropivacaine
high dose groupActive comparatorPatients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.
Receives: Drug: 1.5 ml/kg of 0.15% ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 1 day

Secondary outcomes (2)

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

    Measured: 30 minutes

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

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 May 2016 (estimated)
  2. Study startMay 2016
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02768493
Sponsor's protocol ID
4-2016-0192
Status last verified
Sep 2016
First submitted
8 May 2016
Last updated
9 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 17384377

  • 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.

    PubMed 21505900

  • 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.

    PubMed 22258019

  • 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.

    PubMed 24972788

  • 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.

    PubMed 28486629

Questions about this trial

What is this clinical trial studying?

A study testing 1.0 ml/kg of 0.15% ropivacaine and 1.5 ml/kg of 0.15% ropivacaine in people with Orchiopexy and Inguinal Hernioplasty, run by Yonsei University at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in the optic nerve sheath diameter between groups (time frame: 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02768493, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2016.

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