Breast Cancer Clinical Trial
Official title:
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
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.
n/a
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