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Osteotomy of Lower ExtremityNCT03911804

The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients

A study testing bolus group and infusion group for epidural block in people with Osteotomy of Lower Extremity, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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 continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Read more about this study

Who is it for?
Ages 4 to 13 years
Conditions the study is for
Osteotomy of Lower Extremity
What is being tested?
bolus group and infusion group for epidural block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
Apr 2019to Mar 2021
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 4 to 13 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 1. Pediatric patients from 4 to 13 years of age undergoing osteotomy of lower extremity

Who cannot join

  • 1. Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
  • 2. Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
  • 3. Patients with ophthalmic disease or surgery
  • 4. The estimated operation time is less than 180 minutes.
  • 5. All parents of the subject are foreigners or illiterate

Trial locations and contacts

1 site in 1 country.

South Korea1 site, 1 recruiting

  • Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine

    Seoul, 03722

    Yong Seon Choi, MD, Ph.D, +82-2-2228-2412, yschoi@yush.ac

    Recruiting

Other trials in South Korea

About this study

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 continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural analgesia before osteotomy will be divided into bolus group (n=30) and infusion group (n=30). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia. The primary endpoint is the difference in the optic nerve sheath diameter after epidural analgesia measured by optic nerve ultrasonography between groups.

Being tested
bolus group and infusion group for epidural block

What participants receive

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

  • bolus group and infusion group for epidural blockProcedure or surgery

    Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.

Study groups in NCT03911804
Study groupRoleWhat they receive
Bolus groupExperimentalNot described
Receives: Procedure: bolus group and infusion group for epidural block
Infusion groupActive comparatorNot described
Receives: Procedure: bolus group and infusion group for epidural block

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 (ONSD) between groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: Before epidural block

  2. The difference in the optic nerve sheath diameter (ONSD) between groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 30 minutes after epidural block

  3. The difference in the optic nerve sheath diameter (ONSD) between groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 60 minutes after epidural block

  4. The difference in the optic nerve sheath diameter (ONSD) between groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 90 minutes after epidural block

  5. The difference in the optic nerve sheath diameter (ONSD) between groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 120 minutes after epidural block

  6. The difference in the optic nerve sheath diameter (ONSD) between groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 180 minutes after epidural block

Secondary outcomes (6)

  1. The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: Before epidural block

  2. The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 30 minutes after epidural block

  3. The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 60 minutes after epidural block

  4. The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 90 minutes after epidural block

  5. The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 120 minutes after epidural block

  6. The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups

    The optic nerve sheath diameter measured by optic nerve ultrasonography

    Measured: 180 minutes after epidural block

Timeline

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

  1. First posted11 Apr 2019
  2. Study startApr 2019 (estimated)
  3. Primary completionMar 2021 (estimated)
  4. Study completionMar 2021 (estimated)

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03911804
Sponsor's protocol ID
1-2019-0004
Status last verified
Apr 2019
First submitted
9 Apr 2019
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lin Y, Li Q, Liu J, Yang R, Liu J. Comparison of continuous epidural infusion and programmed intermittent epidural bolus in labor analgesia. Ther Clin Risk Manag. 2016 Jul 14;12:1107-12. doi: 10.2147/TCRM.S106021. eCollection 2016.

    PubMed 27471390

  • Padayachy LC, Padayachy V, Galal U, Pollock T, Fieggen AG. The relationship between transorbital ultrasound measurement of the optic nerve sheath diameter (ONSD) and invasively measured ICP in children. : Part II: age-related ONSD cut-off values and patency of the anterior fontanelle. Childs Nerv Syst. 2016 Oct;32(10):1779-85. doi: 10.1007/s00381-016-3068-4. Epub 2016 Sep 20.

    PubMed 27659820

Questions about this trial

What is this clinical trial studying?

A study testing bolus group and infusion group for epidural block in people with Osteotomy of Lower Extremity, 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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Apr 2019. 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?

Results are not available in the source record.

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

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The difference in the optic nerve sheath diameter (ONSD) between groups (time frame: Before epidural block). The study lists 6 primary outcomes in all. 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 NCT03911804, which also lists 2 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 11 Apr 2019.

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