EUCTR2011-006331-35-IT
Active, Not Recruiting
N/A
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 sitesDecember 13, 2012
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Post operative pain syndromes
- Sponsor
- OSPEDALE POLICLINICO S. MATTEO
- Status
- Active, Not Recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •\- 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)
Outcomes
Primary Outcomes
Not specified
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