Clinical trial that compares the safety and efficacy of two locoregional anesthetic techniques used on breast cancer surgery called BRILMA and PEC II block

Phase 1

• Conditions: on-reconstructiva Breast Surgery candidates; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-005057-21-ES
• Lead Sponsor: Hospital Universitario Sant Joan de Reus

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-31
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

Patients scheduled for non reconstructive breast surgery.
Patients age between 18 and 85 years
Preoperative Surgical risk ASA I to III patients
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

Patients scheduled for reconstructive breast surgery.
Preoperative risk :ASA IV patients.
Patient weight under 45 Kg or BMI over 40 kg / m2.
Preoperative Criteria compatible with difficult airway.
High risk of aspiration of gastric contents.
Allergy to local anesthetics or other drugs used in the clinical trial.
Chronic treatment with opioids.
Local or systemic infection
Altered platelet funtion and / or hemostasia factors.
Chronic pain in anterolateral chest portion and/or axila.
Difficulty to understand the pain valoration scales
Reluctance or rejection for anesthetic technique.
Lack of capacity or willingness to participate in the study and to sign the informed consent form.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified