NCT01389934

Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Basque Health Service · Other Government
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Local Anesthetic

Interventions

Type	Name	Description
DRUG	levo-bupicaine	Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention
DRUG	Placebo	Women of this group be infused saline 2 ml / h for 48h.

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-01-01
• Completion: 2012-01-01
• First posted: 2011-07-08
• Last updated: 2012-02-03

Locations

1 site across 1 country: Spain