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

Study Overview
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Brief Summary
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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.

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

Conditions
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Local Anesthetic

Intervention / Treatment
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* Drug: levo-bupicaine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>Women of this group be infused saline 2 ml / h for 48h. | Drug: Placebo<br>* Women of this group be infused saline 2 ml / h for 48h.<br>|
| Experimental: levo-bupicaine<br>Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h. | Drug: levo-bupicaine<br>* Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness of administering levo-bupicaine to control postoperative pain. | the control postoperative pain will be measured by a a patient satisfaction scale (very good, good, fair, bad, very bad) | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decreased consumption of other analgesics | 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. | 48 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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levo-bupicaine, Radical, Mastectomy