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Completed

NCT Number: NCT01389934

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.

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Key information

Conditions

Local Anesthetic

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Txagorritxu Hospital

Vitoria-Gasteiz, Alava, 01009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with operable breast cancer, which will be submitted to modified radical mastectomy
  • Sign informed consent.

Exclusion criteria

  • Mastectomy without lymphadenectomy
  • Over 80 years
  • Cognitive impairment and patients with serious psychiatric disorders before diagnosis of the cancer process
  • Severe liver or kidney disease
  • Patients allergic or intolerant to any of the drugs used in the study protocol.
  • Regular users of analgesics or narcotics

Treatment and study plan

levo-bupicaine

Drug

Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention

Placebo

Drug

Women of this group be infused saline 2 ml / h for 48h.

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jul 8, 2011
Registry last updated
Feb 3, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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