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.

Study Overview

• Status: Completed
• Conditions: Local Anesthetic
• Intervention / Treatment: Drug: Placebo; Drug: levo-bupicaine

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Alava
    • Vitoria-gasteiz, Alava, Spain, 01009
      • Txagorritxu Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Basque Health Service

Publications and helpful links

General Publications

• Ferreira Laso L, Lopez Picado A, Antonanzas Villar F, Lamata de la Orden L, Ceballos Garcia M, Ibanez Lopez C, Pipaon Ruilope L, Lamata Hernandez F, Valero Martinez C, Aizpuru F, Hernandez Chaves R. Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy. Clin Drug Investig. 2015 Sep;35(9):575-82. doi: 10.1007/s40261-015-0316-4.
• Ferreira Laso L, Lopez-Picado A, Lamata L, Ceballos Garcia M, Ibanez Lopez C, Pipaon Ruilope L, Lamata Hernandez F, Antonanzas Villar F, Valero Martinez C, Aizpuru F, Hernanz Chaves R. Postoperative analgesia by infusion of local anesthetic into the surgical wound after modified radical mastectomy: a randomized clinical trial. Plast Reconstr Surg. 2014 Dec;134(6):862e-870e. doi: 10.1097/PRS.0000000000000762.

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 5, 2011
• First Submitted That Met QC Criteria: July 7, 2011
• First Posted (Estimate): July 8, 2011

Study Record Updates

• Last Update Posted (Estimate): February 3, 2012
• Last Update Submitted That Met QC Criteria: February 2, 2012
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Mastectomy; levo-bupicaine; Radical
• Other Study ID Numbers: MASTEC-002