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Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence of chronic pain 3 months after breast cancer surgery.
Full description
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.
Enrollment
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Inclusion criteria
Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by:
18 years ≤ Age ≥ 85 years.
ASA class 1, 2 or 3.
No analgesic treatment for 2 days (no pre-existing chronic pain)
If a biological control has been requested recently or deemed necessary by the Investigator, then it should be satisfactory : Adequate hematologic and hemostasis: neutrophil count (ANC) > 1500/mm3, haemoglobin > 9 g/dl and platelets > 75 000/mm3, prothrombin time > 70%, activated partial thromboplastin time < 1.5 X Upper Limit of Normal (ULN)
Life expectancy ≥ 2 years.
Signed informed consent form.
Patient able to meet the self-assessments questionnaires (sufficient understanding assessments, proficiency in French)
Patient affiliated with a health insurance scheme (beneficiary or legal)
There is no prohibition for people to take part simultaneously in another search and there is no exclusion cause at the end of the research period.
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Interventional model
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380 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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