Double-blind Study to Assess effectIveness of Pectoral Nerves Block After Breast Surgery on Piritramide Consumption

This is a double-blind study that will randomise breast cancer subjects in 1:1 ratio to receive a "pecs block" of 10 ml of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm A) versus 10 ml of placebo (NaCl 0.9%) injected between pectoral muscles and 20 ml between the muscles pectoralis minor and serratus anterior (arm B). The pecs block will inject just before the surgery.

Subjects will receive a nausea and vomiting prophylaxy depending on Apfel score After surgery, the two intervention groups will receive before waking a dose of Paracetamol (1 g) and Diclofenac (75 mg), if they present no contraindications and a dose of 0.05 mg/kg Piritramide .

In the recovery room the two groups will benefit from a Patient Controlled Intravenous Analgesia (PCIA) pump - Piritramide allowing them to control their analgesia, which will be stopped at 24 hours postoperatively.

Inclusion criteria

• Age ≥18 years old
• Female
• Subjects undergoing either a conservative or non-conservative breast surgery associated with axillary dissection
• ASA score ≤ 3
• Completion of all necessary screening procedures within 30 days prior to randomisation
• Adequate Renal Function including: Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml/min as calculated using the method standard for the institution
• Adequate Liver Function, including all of the following parameters:

• Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 1.5 x ULN If Aspartate and Alanine aminotransferase (AST and ALT) are > 1.5 x ULN, total serum bilirubin should be assessed and must be ≤ 1.5 x ULN unless the patient has documented Gilbert Syndrome
• Alkaline phosphatase ≤ 2.5 x ULN
• Signed informed consent
• Willingness and ability to comply with the study scheduled visits, treatment plans, laboratory tests and other procedures

Exclusion criteria

• Any illness or medical condition that is unstable or could jeopardize the safety of the patient or her compliance with study requirements
• Allergy to local anaesthetics
• Known allergy or hypersensitivity to Paracetamol, Diclofenac, Piritramide or excipients
• Coagulopathy or taking oral anticoagulant/ antiaggregant within 7 days prior to surgery
• BMI> 35 kg / m2
• Infection near the puncture site
• Inability to understand the pain assessment scales (VAS and McGill questionnaire)
• Severe hepatic impairment: elevated transaminases with factor V ≤ 50%
• Severe heart failure: NYHA classification III or IV and/or LVEF < 50%
• Pregnant or lactating women
• Concurrent treatment with daily basis chronic opiate type painkillers not ended 1 month prior surgery
• Scheduled breast reconstruction at the time of surgery
• Metastatic subjects
• Subjects with breast implants
• Patients that require bilateral mastectomy or bilateral lumpectomy