The Combination of PECS II Block and Parasternal Block for Radical Mastectomy

April 17, 2019 updated by: Emiliano Petrucci, San Salvatore Hospital of L'Aquila

The Combination of PECS II Block and Parasternal Block Provide Useful Analgesia After Radical Mastectomy With Axillary Dissection and Implant Breast Reconstruction

The combination of PECS II and parasternal Block provides analgesia after radical mastectomy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The cambionation of PECS II block and parasternal block

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • L'Aquila
      • Coppito, L'Aquila, Italy, 67100
        • San Salvatore Academic Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ASA status patients:1,2 and 3
  • patients undergoing to radical mastectomy with axillary dissection and breast-implant reconstruction

Exclusion Criteria:

  • patients with allergy to local anesthetics
  • ASA status patients: 4
  • breast anatomy abnormalities
  • neurological diseases
  • septic conditions
  • coagulopathies
  • drug abuse history

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The combination of PECS II and parasternal block performed by injecting Levobupivacaine 0.375% 40 ml, injected between minor and major pectoralis muscles, between minor and serratus muscles and between major and intercostal muscles
Procedure: PECS II and parasternal block
10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.
Other Names:
  • Pectoral nerve block II type and parasternal block
Drug: Levobupivacaine
Levobupivacaine
Other Names:
  • Locali anesthetic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: Numeric Rate Scale
Time Frame: 24 hours after surgery
Postoperative pain evaluated with Numeric Rate Scale, from 0 (no pain) to 10 (worst pain)
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative opiates
Time Frame: From start to the end of surgery
Number of patients needing of equianalgesic mg of intraoperative morphine
From start to the end of surgery
Postoperative opiates
Time Frame: 24 hours after surgery
Number of patients needing of equianalgesic mg of postoperative morphine
24 hours after surgery
Side effects
Time Frame: 24 hours after surgery
Number of patients with postoperative nausea and vomiting
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

San Salvatore Hospital of L'Aquila

Investigators

  • Principal Investigator: Emiliano Petrucci, San Salvatore Academic Hospital of L'Aquila

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

April 12, 2019

Study Registration Dates

First Submitted

November 25, 2018

First Submitted That Met QC Criteria

November 26, 2018

First Posted (Actual)

November 27, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0180910/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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