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

Institut Paoli-Calmettes

Status and phase: Terminated; Phase 3

Conditions: Breast Cancer

Treatments: Drug: physiological saline; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02525211

DOLOSEIN / IPC 2011-005

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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59 participants in 2 patient groups, including a placebo group

Ropivacaine

Experimental group

Description:

Ropivacaine

Treatment:

Drug: Ropivacaine

placebo

Placebo Comparator group

Description:

physiological saline

Treatment:

Drug: physiological saline