MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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MIRs03: A Double-blind Randomized Trial of Paravertebral Block With Ropivacaine Before Breast Cancer Surgery: Effects on Chronic Postoperative Pain

Conditions
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Malignant Neoplasm of Breast

Intervention / Treatment
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* Drug: Saline
* Drug: Ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with non-metastatic invasive breast carcinoma or breast carcinoma in situ treated by: either breast-conserving surgery with axillary lymph node dissection either radical surgery with or without axillary lymph node dissection. 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. Exclusion Criteria: Ongoing neoplasm or history of malignancy other than breast cancer with the exception of: basal cell carcinoma, cervical carcinoma in situ, other treated cancer that has not relapsed during the 5 years preceding inclusion in the trial. Bilateral breast carcinoma at the inclusion Male subjects. Metastatic breast carcinoma at diagnosis (M1). Severe heart, liver and respiratory failure (ASA 4) Allergy to local anesthetics and morphine. Use of analgesics during the 48 hours preceding the surgical procedure. History of breast surgery with painful sequelae Major deformation of the spine Puncture site infection History of substance abuse. Pregnant or lactating women, or women of childbearing potential without effective contraception Subjects deprived of their liberty or under guardianship (including temporary guardianship). Subjects unable to comply with medical follow-up of the trial for geographical, social or psychological reasons.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Saline (30 mL maximum) | Drug: Saline<br> <br> * Other names: NA Cl 0.9%;|
| Experimental: Ropivacaine<br>Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution) | Drug: Ropivacaine<br> <br> * Other names: Naropeine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure the extend of dermatomes blocked | The extent of dermatomes blocked as measured by clinical examination to determine area where temperature perception change | one year after surgery | 
| To measure acute postoperative pain (Visual Analog Scale (VAS) | Patient satisfaction on Visual Analog Scale (VAS) | 48 postoperative hours | 
| To determine analgesic consumption | consumption during the first 48 postoperative hours: morphine paracetamol and ketoprofen | 48 postoperative hours | 
| To examine incidence of nausea and vomiting | Common Toxicity Criteria for Adverse Effects (CTCAE) V4.03 | 48 postoperative hours | 
| To characterize chronic pain (Neuropathic Pain Diagnostic DN4 Questionnaire) | Neuropathic Pain Diagnostic DN4 Questionnaire | 3 months | 
| To evaluate the frequency of chronic pain (BPI questionnaire and Neuropathic Pain Diagnostic (DN4) | BPI questionnaire and Neuropathic Pain Diagnostic (DN4) | 6 and 12 months | 
| To compare presence of lymphedema | Clinical examination | 3, 6 and 12 months | 
| To evaluate anxiety and depression evaluation (Hospital Anxiety and Depression questionnaire (HAD) | Hospital Anxiety and Depression questionnaire (HAD) | 3, 6 and 12 months | 
| To evaluate complications of paravertebral block (CTCAE V4.03) | CTCAE V4.03 | 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 | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Surgery, Paravertebral block, Chronic pain