Local Anesthetic Clinical Trial
Official title:
Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
Background: The use of local anesthetics as a supplement to conventional techniques in
breast surgery is widely reported in the literature. Currently there is controversy
regarding the efficacy of surgery for breast infusion of local anesthetic after surgery. The
aim of this study demonstrate the efficacy of administering a local anesthetic into the
surgical bed of women operated radical mastectomy for breast cancer for the control of
postoperative pain.
Material and methods: double-blind randomized clinical trial. The investigators recruited
patients who underwent modified radical mastectomy that met inclusion and exclusion
criteria. The intervention group were infused with L-bupivacaine 0.50% 2 ml/h for 48 hours,
and saline control group at 2 ml/h during surgery and anesthetic technique 48 hours. Local
anesthetic and rescue medication was identical in both groups.
Statistical analysis: The baseline patient characteristics of the patients were analyzed by
Chi square or Student t always meet criteria of normality, otherwise it will use the
Mann-Whitney. To determine the effectiveness of treatment as well as pain scale adverse
events will be held on chi-square test.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment
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