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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Saline (30 mL maximum) |
|
| Ropivacaine | Experimental | Ropivacaine 7.5 mg/mL (0.35 mL/kg of solution) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug |
|
| |
| Ropivacaine |
| 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 |
| 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) |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre FUMOLEAU, PHD | drci.promotion@curie.fr | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Jean PERRIN | Clermont-Ferrand | 63011 | France | |||
| Centre Léon Bérard |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23340346 | Result | Cohen SP, Raja SN. Prevention of chronic postsurgical pain: the ongoing search for the holy grail of anesthesiology. Anesthesiology. 2013 Feb;118(2):241-3. doi: 10.1097/ALN.0b013e31827d4129. No abstract available. | |
| 23340351 | Result | Albi-Feldzer A, Mouret-Fourme E E, Hamouda S, Motamed C, Dubois PY, Jouanneau L, Jayr C. A double-blind randomized trial of wound and intercostal space infiltration with ropivacaine during breast cancer surgery: effects on chronic postoperative pain. Anesthesiology. 2013 Feb;118(2):318-26. doi: 10.1097/ALN.0b013e31827d88d8. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Drug |
|
|
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 |
| Lyon |
| 69008 |
| France |
| Centre Antoine LACASSAGNE | Nice | 06189 NICE Cedex | France |
| INSTITUT CURIE - Site Paris | Paris | 75005 | France |
| Institut Curie site Saint-Cloud | Saint-Cloud | 92210 | France |
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | 54511 | France |
| 19903919 | Result | Gartner R, Jensen MB, Nielsen J, Ewertz M, Kroman N, Kehlet H. Prevalence of and factors associated with persistent pain following breast cancer surgery. JAMA. 2009 Nov 11;302(18):1985-92. doi: 10.1001/jama.2009.1568. |
| 16698416 | Result | Kehlet H, Jensen TS, Woolf CJ. Persistent postsurgical pain: risk factors and prevention. Lancet. 2006 May 13;367(9522):1618-25. doi: 10.1016/S0140-6736(06)68700-X. |
| 11020770 | Result | Perkins FM, Kehlet H. Chronic pain as an outcome of surgery. A review of predictive factors. Anesthesiology. 2000 Oct;93(4):1123-33. doi: 10.1097/00000542-200010000-00038. No abstract available. |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017670 |
| Sodium Compounds |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |