PECS Block in Breast Surgery: an Observational Multicenter Study

Postoperative Pain Clinical Trial

Official title:

PECS Block in Breast Surgery: an Observational Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414256
• Other study ID #: Va-003
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: January 27, 2017
• Start date: January 2015
• Est. completion date: June 2016

Study information

• Verified date: April 2015
• Source: Ospedale di Circolo - Fondazione Macchi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: June 2016
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Italy	Department of Day Surgery Ospedale di Circolo Varese	Varese	VA

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale di Circolo - Fondazione Macchi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Misure		2 days
Secondary	Complications Regional Anesthesia Related		1 days
Secondary	PostOperative Nausea Rate		2 days
Secondary	Intraoperative Opioids Use		surgical time
Secondary	Postoperative Analgesics		2 days