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

NCT03911804 | Unknown DMC

• 1 other identifier: 1-2019-0004
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Osteotomy of Lower Extremity

Outcome Measures

Primary Outcomes (6)

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

  The optic nerve sheath diameter measured by optic nerve ultrasonography

  Before epidural block

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

  The optic nerve sheath diameter measured by optic nerve ultrasonography

  30 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

  60 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

  90 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

  120 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

  180 minutes after epidural block

Secondary Outcomes (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

  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

  30 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

  60 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

  90 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

  120 minutes after epidural block

Study Arms (2)

Bolus group

EXPERIMENTAL

Procedure: bolus group and infusion group for epidural block

Infusion group

ACTIVE COMPARATOR

Procedure: bolus group and infusion group for epidural block

Interventions

bolus group and infusion group for epidural block PROCEDURE

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.

Bolus group; Infusion group

Eligibility Criteria

• Age: 4 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• \. 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 180 minutes.
• \. All parents of the subject are foreigners or illiterate

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

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

Seoul, 03722, South Korea

RECRUITING

Related Publications (2)

• 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.

  PMID: 27471390 BACKGROUND

• 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.

  PMID: 27659820 BACKGROUND

MeSH Terms

Interventions

Anesthesia, Epidural

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants, care providers and investigators are blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2019
• First Posted: April 11, 2019
• Study Start: April 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

KR (1)