Efficacy and safety of long term wound catheter infusion in patients undergoing mastectomy associated to breast reconstruction: a randomized, double-blind study.

Conditions: Post operative pain syndromes
MedDRA version: 14.1Level: PTClassification code 10026878Term: MastectomySystem Organ Class: 10042613 - Surgical and medical procedures
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2011-006331-35-IT

Lead Sponsor: OSPEDALE POLICLINICO S. MATTEO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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

- 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 < 2000) or renal impairment (Creatiniemia > 2 gr/dL)
- Cardiac disease
- Neurologic or psychiatric disease;
- Coagulation disorders (INR > 1.3, PTT > 44 sec)
- PTLs <100.000/mm3
- BMI > 30
- Allergy to one of the specific drugs under study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>- Reduction of persistent pain (PMPS) incidence;<br>- Reduction of side effects; <br>- Reduction of surgical complication incidence; <br>- Better functional recovery;<br>- 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 Outcome Measures