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

NCT01389934 | Completed Phase 4

• 1 other identifier: MASTEC-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Keywords

levo-bupicaine; Radical; Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Decreased consumption of other analgesics

  48 hours

Study Arms (2)

Control

PLACEBO COMPARATOR

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

Drug: Placebo

levo-bupicaine

EXPERIMENTAL

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

Drug: levo-bupicaine

Interventions

levo-bupicaine DRUG

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

levo-bupicaine

Placebo DRUG

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

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with operable breast cancer, which will be submitted to modified radical mastectomy
• Sign informed consent.

You may not qualify if:

• Mastectomy without lymphadenectomy
• Over 80 years
• Cognitive impairment and patients with serious psychiatric disorders before diagnosis of the cancer process
• Severe liver or kidney disease
• Patients allergic or intolerant to any of the drugs used in the study protocol.
• Regular users of analgesics or narcotics

Sponsors & Collaborators

• Basque Health Service: lead

Study Sites (1)

Txagorritxu Hospital

Vitoria-Gasteiz, Alava, 01009, Spain

Location

Related Publications (2)

• 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.

  PMID: 26305021 DERIVED

• 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.

  PMID: 25415108 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: July 5, 2011
• First Posted: July 8, 2011
• Study Start: July 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: February 3, 2012

Record last verified: 2011-07

Locations

ES (1)