Non-reconstructiva Breast Surgery candidates
Conditions
Interventions
Trade Name: Mepivacaina Inyectable Braun 2% Miniplastico
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: MEPIVACAINE
CAS Number: 96-88-8
Concentration unit: mg/ml milligram(s)/millilit
Sponsors
Hospital Universitario Sant Joan de Reus
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the efficacy and safety of ultrasound-guided BRILMA and PEC II block to reduce peri-operative pain in patients undergoing non reconstructive breast surgery at the University Hospital Sant Joan de Reus;Secondary Objective: To compare the analgesic efficacy of the BRILMA and PEC II block during intraoperative period according to the need for administration of opioids based on the variation of vital constants from the moment of the first surgical incision. To compare the duration of postoperative analgesic effect of the BRILMA and PEC II block using the Numerical Verbal Scale (EVN). To evaluate the safety of BRILMA vs PEC II block, comparing the percentage of complications in each group of patients. To assess the degree of satisfaction with regard to postoperative pain in each group of patients.;Primary end point(s): To reduce de Intraaoperative opioid requirements in patients undergoing non reconstructive breast surger . BRILMA or PEC II Block will be done to patients undergoing non reconstructive breast surgery. Anesthetic induction will be carried out without opioids, and intravenous fentanyl will be administered if BRILMA or PEC II Block in uneffective;Timepoint(s) of evaluation of this end point: Intraoperative period | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To Compare the requirements of conventional Analgesia in patients with BRILMA and PEC II block during the first 24 hours of postoperative time. Assess the analgesic efficacy of BRILMA and PEC II block through Numerica Visual Scale (EVN) EVN considering 0 as absense of pain, 1 or 3 mild pain , 4-6 moderate pain , and over 7 as intense pain;Timepoint(s) of evaluation of this end point: First 24 hours after non-reconstructive Breast Surgery | — |
Countries
Spain
Contacts
Public ContactServicio de Anestesiologia
Hospital Universitario Sant Joan de Reus
Outcome results
None listed