Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
Phase 4
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Female
Local Anesthetic
Female
Local Anesthetic
Trial Information
Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
Inclusion Criteria:
- Patients diagnosed with operable breast cancer, which will be submitted to modified
radical mastectomy
- Sign informed consent.
Exclusion Criteria:
1. Mastectomy without lymphadenectomy
2. Over 80 years
3. Cognitive impairment and patients with serious psychiatric disorders before diagnosis
of the cancer process
4. Severe liver or kidney disease
5. Patients allergic or intolerant to any of the drugs used in the study protocol.
6. Regular users of analgesics or narcotics
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
Outcome Measure:
effectiveness of administering levo-bupicaine to control postoperative pain.
Outcome Description:
the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad)
Outcome Time Frame:
48 hours
Safety Issue:
No
Authority:
Spain: Ethics Committee
Study ID:
MASTEC-002
NCT ID:
NCT01389934
Start Date:
July 2011
Completion Date:
January 2012
Related Keywords:
- Local Anesthetic
- levo-bupicaine
- Radical
- Mastectomy
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