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The Effect of Caudal Block on Optic Nerve Sheath Diameter in Pediatric Patients

NCT ID: NCT05216211

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-09

Study Completion Date

2022-10-30

Brief Summary

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Caudal epidural block has been a widely used regional anesthesia method, especially in pediatric surgery, to provide intraoperative and postoperative analgesia. Studies on non-invasive methods used for intracranial pressure measurement have shown that optic nerve sheath diameter is related to intracranial pressure. Optic nerve sheath diameter measurement has high diagnostic accuracy for detecting increased intracranial pressure in children. The aim of the study is to investigate the effect of the caudal block on optic nerve sheath diameter in pediatric patients.

Detailed Description

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Conditions

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Postoperative Pain Intracranial Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group Caudal

Caudal block with 1 ml / kg, % 0.25 bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

1 ml / kg, % 0.25 bupivacaine

Group Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Bupivacaine Hydrochloride

1 ml / kg, % 0.25 bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* circumcision,
* inguinal hernia,
* undescended testis,
* hydrocele operation

Exclusion Criteria

* neurological or spinal anomaly,
* coagulopathy
* allergy to local anesthetics,
* local infection in the area to be intervention,
* with increased intracranial pressure
* children with any ophthalmic pathology
Minimum Eligible Age

1 Year

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ataturk University

OTHER

Sponsor Role lead

Responsible Party

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Ahmet Murat Yayik

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University School of Medicine

Erzurum, Yakutiye, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Optic nerve Caudal

Identifier Type: -

Identifier Source: org_study_id