Efficacy and safety of long term local anaesthetic intralesional infusion in patients with mammary carcinoma undergoing mastectomy with breast reconstruction: a randomized, double-blind study.

INTERVENTION: Trade Name: CHIROCAINE*5F10ML 2,5MG/ML PPS Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: LEVOBUPIVACAINE HYDROCHLORIDE CAS Number: 27262‐48‐2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2.5‐ Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Intralesional use CONDITION: Post operative pain syndromes ; MedDRA version: 14.1 Level: PT Classification code 10026878 Term: Mastectomy System Organ Class: 10042613 ‐ Surgical and medical procedures Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Anesthesia and Analgesia [E03] PRIMARY OUTCOME: Main Objective: Verify if long term (14 days) local anesthetics infusion into the wound has a greater analgesic efficacy then placebo, assessed as reduction of opioid consumption and reduction of Numeric Rate Scale (NRS). Primary end point(s): Reduction of at least 50% of the area under the analgesic drugs consumption‐time curve in the period between the 2nd and the 14th postoperative day Secondary Objective: Verifiy if the active treatment is able to determine:; ‐ Reduction of persistent pain (PMPS) incidence;; ‐ Reduction of side effects; ; ‐ Reduction of surgical complication incidence; ; ‐ Better functional recovery;; ‐ Quality of life improvement and early return to social life; Timepoint(s) of evaluation of this end point: 14th post operative day SECONDARY OUTCOME: Secondary end point(s): See secondary objective Timepoint(s) of evaluation of this end point: 14th post operative day INCLUSION CRITERIA: ‐ Females 18‐70 years ‐ Classificazione American Society of Anesthesiologists (ASA) I,II ‐ Patients affected by infiltrant breast cancer or in situ cancer (DIN 2 and 3, or LIN 2 and 3 by Tavassoli) scheduled for mastectomy (nipple‐sparing, skin‐sparing, skin‐reducing), sentinel node biopsy and/or anxillary lymoph node dissection and breast reconstruction ‐ Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10