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

This study has been completed.
Information provided by:
Basque Health Service Identifier:
First received: July 5, 2011
Last updated: February 2, 2012
Last verified: July 2011

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.

Condition Intervention Phase
Local Anesthetic
Drug: levo-bupicaine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander

Resource links provided by NLM:

Further study details as provided by Basque Health Service:

Primary Outcome Measures:
  • effectiveness of administering levo-bupicaine to control postoperative pain. [ Time Frame: 48 hours ]
    the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad)

Secondary Outcome Measures:
  • Decreased consumption of other analgesics [ Time Frame: 48 hours ]
    We will measure the number of rescue doses of each drug (acetoaminphen, metamizol, dexketoprofen and morphine) We will include all minor adverse effects (nausea, vomiting ...) as severe (sedacion..) and their resolution.

Enrollment: 80
Study Start Date: July 2011
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Women of this group be infused saline 2 ml / h for 48h.
Drug: Placebo
Women of this group be infused saline 2 ml / h for 48h.
Experimental: levo-bupicaine
Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h.
Drug: levo-bupicaine
Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01389934

Txagorritxu Hospital
Vitoria-gasteiz, Alava, Spain, 01009
Sponsors and Collaborators
Basque Health Service
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lourdes Ferreira, Osakidetza/Basque Health Service Identifier: NCT01389934     History of Changes
Other Study ID Numbers: MASTEC-002
Study First Received: July 5, 2011
Last Updated: February 2, 2012

Keywords provided by Basque Health Service:

Additional relevant MeSH terms:
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on April 26, 2017