Cardiovascular Surgical Procedures
Conditions
Interventions
This is a two-arm, double-blind, randomized controlled, non-inferiority clinical trial. A total of 94 participants meeting the eligibility criteria will be randomly allocated in a 1:1 ratio between Gr
Sponsors
Departamento de Anestesiologia da Faculdade de Medicina de Botucatu
Departamento de Anestesiologia da Faculdade de Medicina de Botucatu
Eligibility
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Individuals of both sexes; aged between 18 and 75 years; body weight greater than or equal to 55 kg; scheduled for elective myocardial revascularization or valve replacement procedure via sternotomy; surgeries involving cardiopulmonary bypass (CPB); having provided written informed consent
Exclusion criteria
Exclusion criteria: Chronic opioid user, defined as more than 3 months of opioid use (excluding tramadol); undergoing thoracic incisions other than sternotomy, excluding chest drain insertion or other incisions for vascular graft harvesting; undergoing emergency surgery, heart transplantation, or surgery without the need for cardiopulmonary bypass; having undergone previous sternotomy; presence of easily detectable cognitive impairment; presenting contraindications to parasternal block analgesia, including coagulation disorders, infection, or malignancy at the puncture site; allergy to the local anesthetic used
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected that the use of ropivacaine at a 0.2% concentration in the superficial parasternal block will be non-inferior to the 0.4% concentration in providing adequate analgesia for the postoperative needs of cardiac surgery patients, as measured by the total morfine consumption within the first 24 hours after extubation | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected that there will be no statistically significant difference in the total length of hospital stay;It is expected that there will be no statistically significant difference in the incidence of complications related to the intervention (superficial parasternal block);It is expected that there will be no statistically significant difference in the incidence of arrhythmias after surgery;It is expected that there will be no statistically significant difference in the incidence of stroke after surgery;It is expected that there will be no statistically significant difference in the incidence of acute kidney injury after surgery;It is expected that there will be no statistically significant difference in the incidence of deep infection after surgery;It is expected that there will be no statistically significant difference in the incidence of hospital readmission within 30 days after discharge;It is expected that there will be no statistically significant difference in the incidence of in-hospital mortality;It is expected that there will be no statistically significant difference in the Numerical Verbal Pain Scale (NVPS) scores at rest and during coughing, 24 hours after the superficial parasternal block;It is expected that there will be no statistically significant difference in the Quality of Recovery-15 (QoR-15) score 48 hours after the block;It is expected that there will be no statistically significant difference in the time between extubation and the request for the first dose of morphine;It is expected that there will be no statistically significant difference in the time to extubation after admission to the ICU;It is expected that there will be no statistically significant difference in the length of stay in the ICU;It is expected that there will be no statistically significant difference in the use of vasoactive drugs in the postoperative period ;It is expected that there will be no statistically significant difference in the incidence of postoperative | — |
Countries
Brazil
Contacts
Public ContactRannier Mendes
Faculdade de Medicina de Botucatu – Universidade Estadual Paulista “Júlio de Mesquita Filho” (UNESP)
Outcome results
None listed