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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | Ropivacaine |
|
| placebo | Placebo Comparator | physiological saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine | Drug | 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 |
| 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). |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel FRANCON, MD | Institut Paoli-Calmettes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daniel FRANCON | Marseille | 13009 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29659182 | Result | Riff C, Guilhaumou R, Marsot A, Beaussier M, Cohen M, Blin O, Francon D. Ropivacaine Wound Infiltration for Pain Management After Breast Cancer Mastectomy: A Population Pharmacokinetic Analysis. Clin Pharmacol Drug Dev. 2018 Nov;7(8):811-819. doi: 10.1002/cpdd.452. Epub 2018 Apr 16. |
| Label | URL |
|---|---|
| official web site of the sponsor | View source |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| physiological saline | Drug | a bolus of 10 ml of physiological saline in the catheter of multi- drilled cicatricial perfusion |
|
- 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). |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000588 |
| Amines |