Erector Spinae Plane Block in Minimal Invasive Cardiac Su... | NCT03825068

Studies
Erector Spinae Plane Block in Minimal Invasive Cardiac Surgery

NCT03825068

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 10, 2020Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

ESP Block
general anesthetic

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

Mar 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

Nov 15, 2018Actual

Primary Completion Date

Nov 30, 2020Estimated

Completion Date

Nov 30, 2020Estimated

First Submitted Date

Jan 30, 2019

First Submission Date that Met QC Criteria

Jan 30, 2019

First Posted Date

Jan 31, 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

Mar 9, 2020

Last Update Posted Date

Mar 10, 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

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ESP block group	Active Comparator	patients receive ESP Bock with local anaesthetics	Procedure: ESP Block
control group	Placebo Comparator	general anaestesia	Drug: general anesthetic

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ESP Block	Procedure	20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide	ESP block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS	PAIN SCORES OF PATIENTS	48 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

elective valve replacement

Exclusion Criteria:

chroic renal failure
chronic liver failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
rasha hamed, lecturer	Contact	01000440773		rashaahmed11@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university	Recruiting	Asyut		71111	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

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
D018681	Anesthetics, General

Ancestor Terms

ID	Term
D000777	Anesthetics
D002492	Central Nervous System Depressants
D045505	Physiological Effects of Drugs
D020228	Pharmacologic Actions

Browse Leaves

Not provided

Browse Branches

Not provided