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. - PT-SM-10-Breast- Long lasting WI - BLLWI

OSPEDALE POLICLINICO S. MATTEO0 个研究点开始时间: 2012年12月13日最近更新: 2013年8月5日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方

OSPEDALE POLICLINICO S. MATTEO