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

This study has been completed.
Sponsor:
Information provided by:
Basque Health Service
ClinicalTrials.gov Identifier:
NCT01389934
First received: July 5, 2011
Last updated: February 2, 2012
Last verified: July 2011
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Infusion of a Local Anaesthetic in the Surgical After Modified Radical Mastectomy With Expander

Resource links provided by NLM:

MedlinePlus related topics: Mastectomy
U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01389934

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

No publications provided

Responsible Party: Lourdes Ferreira, Osakidetza/Basque Health Service
ClinicalTrials.gov Identifier: NCT01389934     History of Changes
Other Study ID Numbers: MASTEC-002
Study First Received: July 5, 2011
Last Updated: February 2, 2012
Health Authority: Spain: Ethics Committee
Spain: Spanish Agency of Medicines

Keywords provided by Basque Health Service:
levo-bupicaine
Radical
Mastectomy

Additional relevant MeSH terms:
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013