Chlorhydrate of Ropivacaine and Breast Cancer Surgery

Study Overview
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Brief Summary
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The aim of the study is to evaluate the effect of local anesthetic (chlorhydrate of ropivacaine) to prevent chronic pain after breast surgery for cancer.

Detailed Description
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An estimated 20-65% of women treated with breast surgery for breast cancer experience chronic pain in the treated breast. Patients will be randomize between: infiltration with chlorhydrate of ropivacaine at the time of breast surgery for cancer versus placebo.Intra-operative analgesia will be standardized as well as peri-operative pain management.

Official Title
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Efficacy of Infiltration of Chlorhydrate of Ropivacaine in the Prevention of Chronic Breast Pain After Surgery for Breast Cancer.

Conditions
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Pain,Postoperative, Breast Neoplasms

Intervention / Treatment
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* Drug: Chlorhydrate de Ropivacaine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer patients treated by conservative surgery with axillary node dissection or treated by mastectomy with or without axillary node dissection or sentinel lymph node biopsy. ASA physical status 1, 2 or 3 With a minimum life expectancy of 2 years Written informed consent Exclusion Criteria: Any previous cancer other than breast cancer Allergies to local anesthesic and morphine Reported history of drug Pregnancy Homolateral breast surgery during the last 3 years Analgesic use pre-operatively Renal, pulmonary or liver major dysfunction Active malignant disease Unable to follow the protocol for any reason

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 |
| --- | --- |
| Experimental: Ropivacaïne<br> | Drug: Chlorhydrate de Ropivacaine<br>* The Ropivacaïne group received 3mg/kg of 0.375% ropivacaïne(0.75% ropivacaïne, Astra, mixed with saline)<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* The PCB group received saline solution in equal volume.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the frequencies of chronic breast pain 3 months after breast surgery evaluated by the Brief Pain Inventory in the two groups. |  | 3 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogic Scale, Patient satisfaction with analgesic, consumption, neuropathic pain and depression/anxiety rating scale |  | 2 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female, Anesthetics,local