Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain... | NCT05514977

Studies
Ultrasound Guided Thoracic ESPB for Post Mastectomy Pain Control, Comparing 2 Dosing Regimens of Lidocaine With Different Drug Volumes

NCT05514977

Sponsor

Cairo University

Status

Unknown status

Last Update Posted

Aug 25, 2022Actual

Enrollment

82Estimated

Phase

Not Applicable

Conditions

Analgesia

Interventions

Erector spine plane block

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

Aug 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2022Estimated

Primary Completion Date

Nov 15, 2022Estimated

Completion Date

Dec 30, 2022Estimated

First Submitted Date

May 19, 2022

First Submission Date that Met QC Criteria

Aug 23, 2022

First Posted Date

Aug 25, 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

Aug 23, 2022

Last Update Posted Date

Aug 25, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The investigators compare 2 different drug regimens using 2 different volumes of lidocaine with the same drug content (i.e. different concentrations) as regards efficacy of post operative analgesia following mastectomy surgery

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

82Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
L group	Active Comparator	Patients are given 20 ml of 2 % lidocaine for ESPB	Procedure: Erector spine plane block
H group	Active Comparator	Patients are given 40 ml of 1 % lidocaine for ESPB	Procedure: Erector spine plane block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erector spine plane block	Procedure	Thoracic ESPB	H group L group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effective analgesia	Morphine supplements needed	First 24 hours

Secondary Outcomes

Measure	Description	Time Frame
Analgesic efficiency	Visual analog scale; ranging from 0 to 10 where 0 is no pain and 10 is pain in its worst form	Every 2 hours in the first 24 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA 2 & 3 for elective breast cancer surgery

Exclusion Criteria:

ASA > 3
BMI > 35 kg/m2
Contraindications to LA (coagulopathy and local infection)
Allergy to the drug
Cardiac, hepatic and renal patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ahmed Kareem	Contact	202 - 01119966884		Dr.ahmedkar@gmail.com

Overall Officials

Name	Affiliation	Role
Ahmed Kareem	Kasr alainy hospital, Cairo University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cairo university		Cairo			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