Clinical trial NCT02525211: Continues Cicatricial Perfusion of Ropivacaine Versus Placebo After Mastectomy : Rehabilitation After Treatment
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2015-08-17
Enrollment: 59
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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,
* 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.

Primary outcomes:
measure: Delay to obtain the three criteria of premature recovery after mastectomy
timeFrame: 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 outcomes:
measure: pain intensity
timeFrame: 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: Analgesics consumption measure
timeFrame: 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: Measure of side effects rate
timeFrame: from surgery up to 3 days after the end of treatment
measure: quality of life evaluation
timeFrame: 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).
Other outcomes:
Locations:
city: Marseille
country: France
facility: Daniel FRANCON
Study officials:
affiliation: Institut Paoli-Calmettes
name: Daniel FRANCON, MD
role: PRINCIPAL_INVESTIGATOR
References: