PECS Block in Breast Surgery: an Observational Multicente... | NCT02414256

Studies
PECS Block in Breast Surgery: an Observational Multicenter Study

NCT02414256

Sponsor

Ospedale di Circolo - Fondazione Macchi

Status

Completed

Last Update Posted

Jan 30, 2017Estimated

Enrollment

250Actual

Phase

Not provided

Conditions

Postoperative Pain

Interventions

regional anesthesia in breast surgery

Countries

Italy

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 2015

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

Jan 2015

Primary Completion Date

Apr 2015Actual

Completion Date

Jun 2016Actual

First Submitted Date

Apr 7, 2015

First Submission Date that Met QC Criteria

Apr 9, 2015

First Posted Date

Apr 10, 2015Estimated

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

Jan 27, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Andrea Luigi Ambrosoli, MD, Ospedale di Circolo - Fondazione MacchiPrincipal Investigator

Lead Sponsor

Ospedale di Circolo - Fondazione MacchiOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

We will enroll patients submitted to breast surgery (in and outsettings) with regional anesthesia.

The blinded observers, in the first 48 hours post-operative, will evaluate (telephone interview in outsetting) the pain intensity through the Numeric Rating Scale ( 0= no pain, 10 = worst possible pain) thereby recording the treatment procedures in accordance with usual clinical practice. At the same time we will evaluate the presence of intraoperative or postoperative complications related to regional anesthesia, the PONV rate (post-operative nausea and vomiting) and the analgesic/antiemetic therapy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
regional anesthesia in breast surgery	Other	In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pain Intensity Misure		2 days

Secondary Outcomes

Measure	Description	Time Frame
Complications Regional Anesthesia Related		1 days
PostOperative Nausea Rate		2 days
Intraoperative Opioids Use

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

ASA I-II-III Patients Written Informed Consent

Exclusion Criteria:

ASA IV Active Heart Failure Coagulation Disease Chronic Pain Allergies to Local Anesthetics

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Patients submitted to breast surgery

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Andrea L Ambrosoli, MD	University Hospital Varese	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Day Surgery Ospedale di Circolo Varese		Varese	VA	21100	Italy

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
D000765	Anesthesia, Conduction

Ancestor Terms

ID	Term
D000758	Anesthesia
D000760	Anesthesia and Analgesia

Browse Leaves

Not provided

Browse Branches

Not provided