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

NCT ID: NCT03911804

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Bolus group

Group Type: EXPERIMENTAL

bolus group and infusion group for epidural block

Intervention Type: 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.

Infusion group

Group Type: ACTIVE_COMPARATOR

bolus group and infusion group for epidural block

Intervention Type: 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.

Interventions

bolus group and infusion group for epidural block

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Site Status: RECRUITING

Countries

South Korea

Facility Contacts

Yong Seon Choi, MD, Ph.D

Role: primary

yschoi@yush.ac

+82-2-2228-2412

References

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.

Reference Type: BACKGROUND

PMID: 27471390 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27659820 (View on PubMed)

Other Identifiers

1-2019-0004

Identifier Type: -

Identifier Source: org_study_id