Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander
Status:
Completed
Trial end date:
2012-01-01
Target enrollment:
Participant gender:
Summary
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.