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

Study Overview
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Brief Summary
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The combination of PECS II and parasternal Block provides analgesia after radical mastectomy

Detailed Description
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The cambionation of PECS II block and parasternal block

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: PECS II and parasternal block
* Drug: Levobupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>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<br>* 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.<br>* Other names: Pectoral nerve block II type and parasternal block;Drug: Levobupivacaine<br>* Levobupivacaine<br>* Other names: Locali anesthetic;|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PECS II block, parasternal block, analgesia