TPVB, PECSB, ESPB for Postmastectmy Pain | NCT05076773

Studies
TPVB, PECSB, ESPB for Postmastectmy Pain

NCT05076773

Sponsor

Menoufia University

Status

Completed

Last Update Posted

Oct 13, 2021Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Pain, Postoperative

Interventions

Ultrasound guided block
IV morphine

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

Sep 2021

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

Apr 10, 2019Actual

Primary Completion Date

Aug 10, 2021Actual

Completion Date

Aug 10, 2021Actual

First Submitted Date

Sep 14, 2021

First Submission Date that Met QC Criteria

Sep 29, 2021

First Posted Date

Oct 13, 2021Actual

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

Sep 29, 2021

Last Update Posted Date

Oct 13, 2021Actual

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

Aim of the work The aim of the study is to compare between the effects of ultrasound guided thoracic paravertebral block, pectoral nerve block II, and erector spinae block in management of pain during cancer breast surgeries. The hypothesis of the study is that the three groups will give comparative results.

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

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Group (D)	Placebo Comparator	Patient will receive opioid only for management of their perioperative pain	Drug: IV morphine
Paravertebral block Group (A)	Active Comparator	Will receive thoracic paravertebral block	Procedure: Ultrasound guided block Drug: IV morphine
Pectoral block Group (B)	Active Comparator	Will receive pectoral 1 and 2 block	Procedure: Ultrasound guided block Drug: IV morphine
Erector spinae block Group (C)	Active Comparator	Will receive erector spinae block	Procedure: Ultrasound guided block Drug: IV morphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ultrasound guided block	Procedure	Giving one regional block	Erector spinae block Group (C) Paravertebral block Group (A) Pectoral block Group (B)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary outcome of the study will be duration of analgesia (time to first rescue analgesia after administration of the block).	minutes	0-24o minutess

Secondary Outcomes

Measure	Description	Time Frame
Postoperative pain	assessed by VAS score (0-10) where 0=no pain and 10=worst pain	48 hours
Total morphine consumption	recorded postoperatively in mg

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA physical status classification class I or II
Age group 18 - 60 years of the female gender
Patients undergoing breast cancer surgeries

Exclusion Criteria:

Patient refusal
History of hypersensitivity to local anesthetics
Bleeding disorders or patients receiving anticoagulants
Spine or chest wall deformities
Pregnancy
Local infection at the site of injection.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
kareem M mikhimer, m.sc	assistant fellow, Ahmed Maher Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine Menofia University		Shibīn al Kawm	Menofia	32511	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Title only

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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
D009020	Morphine

Ancestor Terms

ID	Term
D009022	Morphine Derivatives
D009019	Morphinans
D053610	Opiate Alkaloids
D000470	Alkaloids

Browse Leaves

Not provided

Browse Branches

Not provided