NCT01389934

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

Completed Phase 4 Last updated 2 February 2012

What this trial tests

Phase 4 trial testing levo-bupicaine in Local Anesthetic in 80 participants. Completed in 1 January 2012.

Timeline

1 July 2011

Primary endpoint
1 January 2012

1 January 2012

Quick facts

Lead sponsor	Basque Health Service
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	80
Start date	1 July 2011
Primary completion	1 January 2012
Estimated completion	1 January 2012
Sites	1 location across Spain

Drugs / interventions tested

• levo-bupicaine — full drug profile →
• Placebo

Conditions studied

• Local Anesthetic — all drugs for Local Anesthetic →

Sponsor

Basque Health Service — full company profile →

Who can join

Adults 18 to 80, female only, with Local Anesthetic. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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)

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cost-effectiveness analysis of levobupivacaine 0.5 %, a local anesthetic, infusion in the surgical wound after modified radical mastectomy.
   Ferreira Laso L, López Picado A, Antoñanzas Villar F, Lamata de la Orden L, et al · · 2015 · cited 1× · PMID 26305021 · DOI 10.1007/s40261-015-0316-4