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

Phase 4

Completed

• Conditions: Local Anesthetic
• Interventions: Drug: Placebo; Drug: levo-bupicaine

• Registration Number: NCT01389934
• Lead Sponsor: Basque Health Service

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-07
• Study Start: 2011-07
• Study First Submitted: 2011-07-05
• Study First Submitted QC: 2011-07-07
• Study First Posted: 2011-07-08
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-02-02
• Last Update Posted: 2012-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Women of this group be infused saline 2 ml / h for 48h.
levo-bupicaine	levo-bupicaine	Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h.

Primary Outcome Measures

Name	Time	Method
effectiveness of administering levo-bupicaine to control postoperative pain.	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

Name	Time	Method
Decreased consumption of other analgesics	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.

Trial Locations

Locations (1)

Txagorritxu Hospital; 🇪🇸 Vitoria-gasteiz, Alava, Spain