Bilateral Erector Spinae Plane Block in Paediateric Cardi... | NCT04168177

Studies
Bilateral Erector Spinae Plane Block in Paediateric Cardiac Surgery

NCT04168177

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jun 16, 2020Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Pain Management

Interventions

Countries

Egypt

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

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 17, 2019Actual

Primary Completion Date

Jul 17, 2020Estimated

Completion Date

Dec 20, 2020Estimated

First Submitted Date

Feb 20, 2019

First Submission Date that Met QC Criteria

Nov 16, 2019

First Posted Date

Nov 19, 2019Actual

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

Jun 11, 2020

Last Update Posted Date

Jun 16, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Rasha Hamed, lecturer of anaesthesia and pain management, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

ultrasound guided erector spinae plane block will be done for childern under going midline sternotomy for cardiac surgery. It is a novel block which is suspected to give powerful analgesia, decrease anaesthetic consumption and decrease awareness on cardiac bypass

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

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
control group	Active Comparator		Procedure: PCA
ESP Group	Active Comparator		Procedure: ESP

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PCA	Procedure	Patient controlled analgesia	control group
ESP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
visual analogue score	pain scores will be assessed by anaesthesia and ICU nurse. zero mean no pain an 10 indicate the worst pain.	48 hours

Secondary Outcomes

Measure	Description	Time Frame
intraoperative anaesthetic consumption		6 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective surgery
childern between 4 and 10 years

Exclusion Criteria:

emergency
infection at injection site
allergy to local anaestheics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

12 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
Assiut university	Recruiting	Asyut		71111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000377	Agnosia

Ancestor Terms

ID	Term
D010468	Perceptual Disorders
D019954	Neurobehavioral Manifestations
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010323	Passive Cutaneous Anaphylaxis

Ancestor Terms

ID	Term
D012882	Skin Tests
D007159	Immunologic Tests
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures

Browse Leaves

Not provided

Browse Branches

Not provided