The Effect of Caudal Block on Optic Nerve Sheath Diameter... | NCT05216211

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

NCT05216211

Sponsor

Ataturk University

Status

Completed

Last Update Posted

Dec 23, 2022Actual

Enrollment

60Actual

Phase

Not Applicable

Conditions

Postoperative Pain
Intracranial Hypertension

Interventions

Bupivacaine Hydrochloride

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2021Actual

Primary Completion Date

Sep 1, 2022Actual

Completion Date

Oct 30, 2022Actual

First Submitted Date

Dec 9, 2021

First Submission Date that Met QC Criteria

Jan 18, 2022

First Posted Date

Jan 31, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 22, 2022

Last Update Posted Date

Dec 23, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group Caudal	Active Comparator	Caudal block with 1 ml / kg, % 0.25 bupivacaine	Drug: Bupivacaine Hydrochloride
Group Control	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bupivacaine Hydrochloride	Drug	1 ml / kg, % 0.25 bupivacaine	Group Caudal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Optic Nerve Diameter	Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes	First minute
Optic Nerve Diameter	Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes	5th minutes
Optic Nerve Diameter	Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes	15th minutes
Optic Nerve Diameter	Consecutive Optic Nerve Sheath Diameter Measurement from Both Eyes	30th minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

7 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ataturk University School of Medicine		Erzurum	Yakutiye	25100	Turkey (Türkiye)

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative
D019586	Intracranial Hypertension

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002045	Bupivacaine

Ancestor Terms

ID	Term
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds

Browse Leaves

Not provided

Browse Branches

Not provided