Post operative pain syndromes MedDRA version: 14.1 Level: PT Classification code 10026878 Term: Mastectomy System Organ Class: 10042613 - Surgical and medical procedures
Conditions
Interventions
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/m
Sponsors
OSPEDALE POLICLINICO S. MATTEO
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: - Preoperative chest or arm pain - Use of analgesic drugs before surgery - Alcol/drug addiction - Emergency/urgency surgery - Postoperative admission in an intensive care unit - Cognitive impairment or mental retardation - Severe hepatic (INR>2 and/or cholinestarasis 2 gr/dL) - Cardiac disease - Neurologic or psychiatric disease; - Coagulation disorders (INR > 1.3, PTT > 44 sec) - PTLs 30 - Allergy to one of the specific drugs under study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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).;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;;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;Timepoint(s) of evaluation of this end point: 14th post operative day | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): See secondary objective;Timepoint(s) of evaluation of this end point: 14th post operative day | — |
Countries
Italy
Contacts
Public ContactStruttura di Terapia del Dolore
Fondazione IRCCS Policlinico San Matteo
Outcome results
None listed