Ultrasound Guided Erector Spinae Plane Block in Breast Su... | NCT03660020

Studies
Ultrasound Guided Erector Spinae Plane Block in Breast Surgery

NCT03660020

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 9, 2020Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Local anesthetic
Hyaluronidase

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

Apr 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

May 19, 2018Actual

Primary Completion Date

Nov 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Jul 20, 2018

First Submission Date that Met QC Criteria

Sep 4, 2018

First Posted Date

Sep 6, 2018Actual

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

Apr 7, 2020

Last Update Posted Date

Apr 9, 2020Actual

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

hyalorounidase will be added to local anaesthetics in patients undergoing mastectomy and effect on local anaesthetic spread will be studied under floroscope

Detailed Description

two groups will be enrolled the control group will receive local anaethetic only and the spread will be observed by floroscope. the seconed group, hyaloronidase will be added to local anaesthetics and the spread will be studied under image.

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

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
local anaesthetic group	Sham Comparator		Drug: Local anesthetic
hyalorounidase group	Active Comparator		Drug: Hyaluronidase

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Local anesthetic	Drug	ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only	local anaesthetic group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
degree of local anaesthetics spread after injection in both group	spread of local anaesthics will be examined under floroscopic guide	10 minutes after block

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Female
ASA I, II, III
Elective surgery

Exclusion Criteria:

Patient refusal
Infection at injection site
Allergy to the given drugs

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
rasha HAMED	Contact	088-01000440773		rashaahmed11@yahoo.com
saeid elsawy	Contact	088-01030072161		saeedelsawy17@gmail.com

Overall Officials

Name	Affiliation	Role
saeid elsawy	Assiut University	Study Chair

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
D000779	Anesthetics, Local
D006821	Hyaluronoglucosaminidase

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