NCT02414256

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 10, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

January 30, 2017

Status Verified

April 1, 2015

Enrollment Period

3 months

First QC Date

April 7, 2015

Last Update Submit

January 27, 2017

Conditions

Postoperative Pain

Keywords

breast surgery

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Misure

    2 days

Secondary Outcomes (4)

  • Complications Regional Anesthesia Related

    1 days

  • PostOperative Nausea Rate

    2 days

  • Intraoperative Opioids Use

    surgical time

  • Postoperative Analgesics

    2 days

Interventions

regional anesthesia in breast surgeryOTHER

In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients submitted to breast surgery

You may qualify if:

  • ASA I-II-III Patients Written Informed Consent

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Day Surgery Ospedale di Circolo Varese

Varese, VA, 21100, Italy

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Study Officials

  • Andrea L Ambrosoli, MD

    University Hospital Varese

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 7, 2015

First Posted

April 10, 2015

Study Start

January 1, 2015

Primary Completion

April 1, 2015

Study Completion

June 1, 2016

Last Updated

January 30, 2017

Record last verified: 2015-04

Locations

IT(1)