Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment

Study Overview
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Brief Summary
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The acute pain care, in particular after breast cancer surgery must be early and quickly effective, because a severe postoperative pain increases the risk of chronic pain and exposes to a risk of important embarrassment for the realization of simple daily movements. Associated to conventional analgesics administered by systemic way, a local anesthesic (ropivacaine) can be continuously infused (Continues Cicatricial Perfusion CCP) in the operating wound by a multi-drilled catheter by means of a elastomeric diffuser set up in the surgical unit by the surgeon at the end the surgical procedure. Besides the control of the postoperative acute pain, the local anesthesic could intervene in the prevention of the chronic pain, the early recovery, the reduction of the neuropathic pains and the decrease of needs in morphine after mastectomy. The duration of hospitalization being lower than 48 hours for this type of surgery, the investigators envisage an immediate follow-up in the Units of Care then at home, what will require a training of the hospital actors and at home (patient, family, visiting nurse, general practitioner). Although proposed for several years, the CCP after breast surgery is still a little spread technique and few works had evaluated the pain at rest and at mobilization after mastectomy, the early rehabilitation, and to spread its use towards home, that is why we propose a randomized double-blind study ropivacaine / placebo in patients after mastectomy.

Official Title
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Double-blind Randomized Prospective Phase III Study of a Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment of the Postoperative Pain From Hospital to Home

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Ropivacaine
* Drug: physiological saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women > 18 years, Operated for a breast cancer by mastectomy with or without lymph node dissection, without immediate reconstruction, Capable of understanding the antalgic protocol, No contraindication to the local anesthesics, Social security affiliation, Signed informed consent. Exclusion Criteria: Preoperative radiotherapy, Local infection, Contra-indication to the local anesthetic or to CCP, Contra-indication for the use of morphine, Contra-indication for the use of remifentanil, Addiction to opioid analgesics know or not, Allergy to local anesthetics, Hepatic or renal impairment grim known, Previous surgery on the operated breast, Pregnant women, or child-bearing potential, or lactating women, Patient deprived of liberty or under supervision of a guardian.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>Ropivacaine | Drug: Ropivacaine<br>* a bolus of 10 ml of ropivacaine 7,5 mg / l then by a diffuser of local anesthesic (Ropivacaine 2mg / ml in continuous flow 10ml / hour) connected on the catheter the day after the intervention before returning at home<br>|
| Placebo Comparator: placebo<br>physiological saline | Drug: physiological saline<br>* a bolus of 10 ml of physiological saline in the catheter of multi- drilled cicatricial perfusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delay to obtain the three criteria of premature recovery after mastectomy | Delay to obtain the three criteria of premature recovery after mastectomy until 3 months post surgery:satisfactory analgesia defined by a Digital Scale lower than 4, estimated at rest and after standardized mobilization in immediate postoperative, and recourses or not to an analgesia of help, and capacity to drink with a glass and to thread the sleeve of a garment with the member side of the operated breast. | time from surgery up to 6 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | postoperative global and neuropathic pain scale | time from surgery up to 6 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6). | 
| Analgesics consumption measure | - Consumption of analgesics taken at request, in particular morphine savings in immediate postoperative | time from surgery up to 3 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 3 and month 6). | 
| Measure of side effects rate | - Side effects evaluated according to CTC-AE V4 (COMMON TERMILOLOGY CRITERIA FOR ADVERSE EVENTS version 4) | from surgery up to 3 days after the end of treatment | 
| quality of life evaluation | - Satisfaction and quality of life of the patients evaluated by scale and questionaries (QLQ-C30)at inclusion, month 1, month 3. | time from surgery up to 3 months (At day of surgery, and at day 1, day 2, day 3 and day 15, then at month 1 and month 3). |