Cerebral PalsyNCT03200951
The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy
A study testing Bolus group for epidural block and Infusion group for epidural block in people with Cerebral Palsy, run by Yonsei University at 1 site in South Korea.
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 epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. Read more about this study
- Who is it for?
- Ages 4 to 13 years
- Conditions the study is for
- Cerebral Palsy
- What is being tested?
- Bolus group for epidural block and Infusion group for epidural block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 Aug 2017to 31 May 2018
- 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
- Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy
- Body weight ≤ 40 kg
Who cannot join
- Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
- Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
- Patients with ophthalmic disease or surgery
- The estimated operation time is less than 70 minutes.
- All parents of the subject are foreigners or illiterate
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, 03722
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 epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve sheath diameter after epidural block measured by optic nerve ultrasonography between groups.
- Conditions
- Cerebral Palsy
- Being tested
- Bolus group for epidural block, Infusion group for epidural block
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bolus group for epidural blockDrug
Also called ripivacaine
Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.
Infusion group for epidural blockDrug
Also called ripivacaine
Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
| Study group | Role | What they receive |
|---|---|---|
| Bolus group | Experimental | Not described Receives: Drug: Bolus group for epidural block |
| Infusion group | Active comparator | Not described Receives: Drug: Infusion group for epidural block |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the optic nerve sheath diameter(ONSD) between groups
The optic nerve sheath diameter measured by optic nerve ultrasonography.
Measured: 5 minutes before epidural block
The difference in the optic nerve sheath diameter(ONSD) between groups
The optic nerve sheath diameter measured by optic nerve ultrasonography.
Measured: 1 second after epidural block
The difference in the optic nerve sheath diameter(ONSD) between groups
The optic nerve sheath diameter measured by optic nerve ultrasonography.
Measured: 10 minutes after epidural block
The difference in the optic nerve sheath diameter(ONSD) between groups
The optic nerve sheath diameter measured by optic nerve ultrasonography.
Measured: 70 minutes after epidural block
Secondary outcomes (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: 5 minutes before epidural block
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: 1 second after epidural block
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: 10 minutes after epidural block
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: 70 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.
- First posted27 Jun 2017
- Study start22 Aug 2017
- Primary completion31 May 2018
- Study completion31 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cerebral PalsyStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 of 0.15% ripivacaine for epidudral block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03200951
- Sponsor's protocol ID
- 4-2017-0341
- Status last verified
- Oct 2018
- First submitted
- 22 Jun 2017
- Last updated
- 29 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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 27471390Padayachy 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients With Cerebral Palsy
- ClinicalTrials.gov ID
- NCT03200951
- Acronym / sponsor ID
- 4-2017-0341
- Conditions
- Cerebral Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- 22 Aug 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 27 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 epidural block on intracranial pressure in pediatric patients with cerebral palsy undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural block before osteotomy will be divided into bolus group (n=20) and infusion group (n=20). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. The primary endpoint is the difference in the optic nerve sheath diameter after epidural block measured by optic nerve ultrasonography between groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidudral block. In contrast, patients in the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
| Arm | Type | Receives |
|---|---|---|
| Bolus group | Experimental | Drug: Bolus group for epidural block |
| Infusion group | Active comparator | Drug: Infusion group for epidural block |
Who may qualify
- Ages
- 4 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Pediatric patients with cerebral palsy from 4 to 13 years of age undergoing osteotomy
- Body weight ≤ 40 kg
Key exclusion criteria (5 listed)
- Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
- Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
- Patients with ophthalmic disease or surgery
- The estimated operation time is less than 70 minutes.
- All parents of the subject are foreigners or illiterate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bolus group for epidural blockAlso: ripivacaineRandomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block. | Drug | Bolus group |
| Infusion group for epidural blockAlso: ripivacaineRandomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block. | Drug | Infusion group |
Primary outcome
The difference in the optic nerve sheath diameter(ONSD) between groups
Time frame: 5 minutes before epidural block
The optic nerve sheath diameter measured by optic nerve ultrasonography.
The difference in the optic nerve sheath diameter(ONSD) between groups
Time frame: 1 second after epidural block
The optic nerve sheath diameter measured by optic nerve ultrasonography.
The difference in the optic nerve sheath diameter(ONSD) between groups
Time frame: 10 minutes after epidural block
The optic nerve sheath diameter measured by optic nerve ultrasonography.
The difference in the optic nerve sheath diameter(ONSD) between groups
Time frame: 70 minutes after epidural block
The optic nerve sheath diameter measured by optic nerve ultrasonography.
4 secondary outcomes
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
Time frame: 5 minutes before epidural block
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
Time frame: 1 second after epidural block
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
Time frame: 10 minutes after epidural block
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
Time frame: 70 minutes after epidural block
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2018.
- Background: PubMed 27471390Lin 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.
- Background: PubMed 27659820Padayachy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bolus group for epidural block and Infusion group for epidural block in people with Cerebral Palsy, 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 2 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: finished, as of the sponsor's last update on 29 Oct 2018. 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(ONSD) between groups (time frame: 5 minutes before epidural block). The study lists 4 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 NCT03200951, 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 29 Oct 2018.