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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Ropivacaine 3.5 mg/ml
Clonidine 5µg/ml
Sodium Chloride 0.9 %
Institut Jules Bordet
Brussels, Belgium
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
Time frame: 24 hrs post-surgery
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)
Time frame: 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
Time frame: 48 hours post-surgery
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