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PECS Block in Breast Surgery: an Observational Multicenter Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02414256
First Posted: April 10, 2015
Last Update Posted: January 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi
  Purpose

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.


Condition Intervention
Postoperative Pain Other: regional anesthesia in breast surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: PECS Block in Breast Surgery: an Observational Multicenter Study

Resource links provided by NLM:


Further study details as provided by Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi:

Primary Outcome Measures:
  • Pain Intensity Misure [ Time Frame: 2 days ]

Secondary Outcome Measures:
  • Complications Regional Anesthesia Related [ Time Frame: 1 days ]
  • PostOperative Nausea Rate [ Time Frame: 2 days ]
  • Intraoperative Opioids Use [ Time Frame: surgical time ]
  • Postoperative Analgesics [ Time Frame: 2 days ]

Enrollment: 250
Study Start Date: January 2015
Study Completion Date: June 2016
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: regional anesthesia in breast surgery
    In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients submitted to breast surgery
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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414256


Locations
Italy
Department of Day Surgery Ospedale di Circolo Varese
Varese, VA, Italy, 21100
Sponsors and Collaborators
Ospedale di Circolo - Fondazione Macchi
Investigators
Study Chair: Andrea L Ambrosoli, MD University Hospital Varese
  More Information

Responsible Party: Andrea Luigi Ambrosoli, MD, Ospedale di Circolo - Fondazione Macchi
ClinicalTrials.gov Identifier: NCT02414256     History of Changes
Other Study ID Numbers: Va-003
First Submitted: April 7, 2015
First Posted: April 10, 2015
Last Update Posted: January 30, 2017
Last Verified: April 2015

Keywords provided by Andrea Luigi Ambrosoli, Ospedale di Circolo - Fondazione Macchi:
breast surgery

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms