COMPARISON OF TWO ULTRASOUND-GUIDED TWO NERVE BLOCKS FOR NOT RECONSTRUCTIVE BREAST SURGERY. RANDOMIZED CLINICAL TRIA

• Conditions: Sheduled patients for nor reconstructive unilateral breast surgery; MedDRA version: 16.0Level: PTClassification code 10057654Term: Breast cancer femaleSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-001829-76-ES
• Lead Sponsor: Paula Diéguez García

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-08
• Last Update Posted: 21 October 2013

Recruitment & Eligibility

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

Inclusion Criteria

Sheduled female patients for not reconstructive unilateral breast surgery ( tumorectomy with oncoplasty or mastectomy, with or without sentinel node and/or linfadenectomy)
Clasification ASA I-III
Firmed informed consent before to the surgery
Aged 18 to 75 years old
Posibility for evaluation of pain through simple verbal scale and numerical scale
Pain down 3 for simple verbal scale in the inclusion moment
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 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

Personal history of disorders of hemostasis and / or previous history of abnormal bleeding evidence
Local infection at the site of the puncture and / or to puncture prior systemic
Contraindications to study medication
Muscle or neurological disease, preexisting peripheral or central
Patients with prior history of opioid
Pregnancy or lactation (women of childbearing age will be a urine pregnancy test prior to surgery the same day of surgery)
Difficulties in assessing pain or inability to understand or assist in the development of the study (psychiatric illness, cognitive impairments).
Active Chronic alcoholism or drug addiction.
BMI <20 or> 30 kg/m2
Chronic treatment with NSAIDs, antidepressants, anticonvulsants or opioids.
Rejection of the patient.

Study & Design

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