Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Ropivacaine Ropivacaine |
Drug: Ropivacaine
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
|
| Placebo Comparator: placebo physiological saline |
Drug: physiological saline
a bolus of 10 ml of physiological saline in the catheter of multi- drilled cicatricial perfusion
|
Outcome Measures
Primary Outcome Measures
- Delay to obtain the three criteria of premature recovery after mastectomy [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).]
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.
Secondary Outcome Measures
- pain intensity [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).]
postoperative global and neuropathic pain scale
- Analgesics consumption measure [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).]
- Consumption of analgesics taken at request, in particular morphine savings in immediate postoperative
- Measure of side effects rate [from surgery up to 3 days after the end of treatment]
- Side effects evaluated according to CTC-AE V4 (COMMON TERMILOLOGY CRITERIA FOR ADVERSE EVENTS version 4)
- quality of life evaluation [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).]
- Satisfaction and quality of life of the patients evaluated by scale and questionaries (QLQ-C30)at inclusion, month 1, month 3.
Eligibility Criteria
Criteria
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,
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No contraindication to the local anesthesics,
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Social security affiliation,
-
Signed informed consent.
Exclusion Criteria:
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Preoperative radiotherapy,
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Local infection,
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Contra-indication to the local anesthetic or to CCP,
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Contra-indication for the use of morphine,
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Contra-indication for the use of remifentanil,
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Addiction to opioid analgesics know or not,
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Allergy to local anesthetics,
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Hepatic or renal impairment grim known,
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Previous surgery on the operated breast,
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Pregnant women, or child-bearing potential, or lactating women,
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Patient deprived of liberty or under supervision of a guardian.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Daniel FRANCON | Marseille | France | 13009 |
Sponsors and Collaborators
- Institut Paoli-Calmettes
Investigators
- Principal Investigator: Daniel FRANCON, MD, Institut Paoli-Calmettes
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- DOLOSEIN / IPC 2011-005