Sheduled patients for nor reconstructive unilateral breast surgery MedDRA version: 16.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Chirocane 5 mg/ml solución inyectable/concentrado para solución para perfusión
Product Name: LEVOBUPIVACAINA
Product Code: N01B B10
Pharmaceutical Form: Concentrate and solvent for concent
Sponsors
Paula Diéguez García
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 30 kg/m2 Chronic treatment with NSAIDs, antidepressants, anticonvulsants or opioids. Rejection of the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the clinical trial is the evaluation of the efficacy of the intercostal branches block in the midaxxilary line and paravertebral block in sheduled female patients for not reconstructive breast surgery.;Secondary Objective: The secundary objectives are: security, difficulty in blockade, patient satisfaction.;Primary end point(s): a) Variables response ? efficacy variables 1. Postoperative pain (measured on arrival in the PACU, at 3h, 6h, 12h, 18h and 24h). a. Verbal scale (VRS): no pain / mild / moderate pain / severe pain / pain unbearable. b. Numerical visual scale (EVN): from 0-10, with 0 being no pain and 10 the worst pain imaginable. So be valued as: EVN 0 the no pain, EVN 7 and severe pain. Two. Rescue opioid requirements: at 24 hours will determine whether: not used any dose / dose was used / is used as much or more than 2 doses. Three. Quality and quantity of sleep: I. Sleep Quality: through verbal categorical scale: bad / average / good. II. Amount of sleep: by recording the number of hours catalogándose as: 6h. ? Safety Variables 1. Percentage of patients with nausea and / or vomiting postoperatively, both assessed as absence / presence of sensation of nausea / vomiting presence / or both. Two. Lock Related (AL systemic toxicity, pneumothorax, paresthesia) Three. Other: such as itching, dizziness, sedation, hypoventilation, etc.. ? Secondary endpoints 1) blockade Difficulty: using the following ratings: ? block performance time recorded in minutes from the moment that starts at ultrasound examination until the blockade ends withdrawing all necessary material. ? existing adipose Panniculus measured in centimeters, by the criterion of depth in the ultrasound image (displayed consistently on the screen), and will be registered prior to puncture and / or injection. ? Complications during the block existing (hematoma, injury to adjacent structures, pleural puncture) ? Difficulty ultrasound visibility: using assessment scal | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a.Evaluar safety of both techniques. b.Evaluar patients' satisfaction regarding the successful block. c.Determinar the difficulty of blockade. d.Registro of the demographic characteristics of the study population, type of surgery, physical and surgical side.;Timepoint(s) of evaluation of this end point: 24 hours postoperative | — |
Countries
Spain
Contacts
Public ContactDra. Diéguez García
Paula Diéguez García
Outcome results
None listed