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

Local Anesthetic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01389934
• Other study ID #: MASTEC-002
• Status: Completed
• Phase: Phase 4
• First received: July 5, 2011
• Last updated: February 2, 2012
• Start date: July 2011
• Est. completion date: January 2012

Study information

• Verified date: July 2011
• Source: Basque Health Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Local Anesthetic

Intervention

Drug:
• levo-bupicaine
Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention
• Placebo
Women of this group be infused saline 2 ml / h for 48h.

Locations

Country	Name	City	State
Spain	Txagorritxu Hospital	Vitoria-gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Basque Health Service

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes