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

Study Overview
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Brief Summary
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The aims of this study is to compare the effectiveness of pecs block associated to a general anesthesia in terms of Piritramide consumption compared with a general anaesthesia alone and the chronic pain incidence in patients that undergoing either a lumpectomy or a mastectomy associated with axillary dissection This is a double-blind, placebo controlled study that will randomise breast cancer subjects in 1:1 ratio to receive a pecs block of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml (arm A) versus placebo (arm B).

Detailed Description
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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.

Official Title
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A Randomised, Double-blind, Placebo-controlled Study to Assess the effectIveness of Pectoral Nerves Block (PECS) After Breast Surgery on Piritramide Consumption

Conditions
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Locoregional Analgesia in Breast Surgery

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: Clonidine
* Drug: Sodium Chloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine + Clonidine<br>A pecs block of Ropivacaine 3.5 mg/ml and Clonidine 5 µg/ml will be injected to the patients prior surgery. 10 ml of the drug combination will be injected between pectoral muscles and 20 ml of the drug combination will be injected between the muscles pectoralis minor and serratus anterior. After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery. | Drug: Ropivacaine<br>* Ropivacaine 3.5 mg/ml<br>Drug: Clonidine<br>* Clonidine 5µg/ml<br>|
| Placebo Comparator: Sodium Chloride<br>A pecs block of Placebo (Sodium Chloride 0.9%) will be injected to the patients prior surgery. 10 ml of the Sodium chloride solution will be injected between pectoral muscles and 20 ml of the Sodium chloride solution will be injected between the muscles pectoralis minor and serratus anterior). After surgery, subjects in both arms will receive one dose of Paracetamol (1g) and Diclofenac (75 mg) and one dose 0.05 mg/kg Piritramide as well as PCIA (Patient Controlled Intravenous Analgesia)-Piritramide for 24 hrs post-surgery. | Drug: Sodium Chloride<br>* Sodium Chloride 0.9 %<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effectiveness of pecs block in terms of total Piritramide consumption | Piritramide consumption in the first 24 h post-surgery will be recorded | 24 hrs post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of incidence of chronic pain in both groups at 6 months postoperatively | Pain intensity until 6 months post-surgery will be evaluated using the Short version of Mc Gill questionnaire (SF-MPQ2) | 6 months post-surgery | 
| Evaluation of present pain post-operatively | Present pain intensity until 48 hrs post- surgery will be assessed by Visual Analog scoring | 48 hours post-surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, lumpectomy, mastectomy, PECS bloc