Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.
Before anesthesia, the second or third intercostal space is located. After an aspiration, 0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then, general anesthesia is induced. Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
380
Centre Jean PERRIN
Clermont-Ferrand, France
Centre Léon Bérard
Lyon, France
Centre Antoine LACASSAGNE
Nice, France
INSTITUT CURIE - Site Paris
Paris, France
To compare chronic pain 3 months after breast surgery in each arm
Percentage of patients who reported chronic pain 3 months after breast surgery in each arm evaluated by the Brief Pain Inventory, French version. Chronic pain is defined by the item 5 of BPI (upper or equal to 3)
Time frame: 3 months
To measure the extend of dermatomes blocked
The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change
Time frame: one year after surgery
To measure acute postoperative pain (Visual Analog Scale (VAS)
Patient satisfaction on Visual Analog Scale (VAS)
Time frame: 48 postoperative hours
To determine analgesic consumption
consumption during the first 48 postoperative hours: morphine paracetamol and ketoprofen
Time frame: 48 postoperative hours
To examine incidence of nausea and vomiting
Common Toxicity Criteria for Adverse Effects (CTCAE) V4.03
Time frame: 48 postoperative hours
To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire)
Neuropathic Pain Diagnostic DN4 Questionnaire
Time frame: 3 months
To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
BPI questionnaire and Neuropathic Pain Diagnostic (DN4)
Time frame: 6 and 12 months
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Institut Curie site Saint-Cloud
Saint-Cloud, France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, France
To compare presence of lymphedema
Clinical examination
Time frame: 3, 6 and 12 months
To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD)
Hospital Anxiety and Depression questionnaire (HAD)
Time frame: 3, 6 and 12 months
To evaluate complications of paravertebral block (CTCAE V4.03)
CTCAE V4.03
Time frame: 12 months
To determine the number of patients reporting pain at 6 months
Clinical examination to confirm the results of Visual analog scale, pain scores BPI and DN4
Time frame: 6 months