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

NCT ID: NCT01389934

Last Updated: 2012-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2012-01-31

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.

Conditions

Local Anesthetic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control

Women of this group be infused saline 2 ml / h for 48h.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Women of this group be infused saline 2 ml / h for 48h.

levo-bupicaine

Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h.

Group Type: EXPERIMENTAL

levo-bupicaine

Intervention Type: DRUG

Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention

Interventions

levo-bupicaine

Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention

Intervention Type: DRUG

Placebo

Women of this group be infused saline 2 ml / h for 48h.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Basque Health Service

OTHER_GOV

Sponsor Role: lead

Responsible Party

Osakidetza/Basque Health Service

Locations

Txagorritxu Hospital

Vitoria-Gasteiz, Alava, Spain

Countries

Spain

References

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.

Reference Type: DERIVED

PMID: 26305021 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25415108 (View on PubMed)

Other Identifiers

MASTEC-002

Identifier Type: -

Identifier Source: org_study_id