Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

Overview

Two-parallel arm, double-blind, individually randomized controlled trial. Primary endpoint: Fentanyl consumption in the first 48 postoperative hours. Secondary endpoints: Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias

Trial design: Two-parallel arm, double-blind, individually randomized controlled trial. Primary endpoint: Fentanyl consumption in the first 48 postoperative hours. Secondary endpoints: Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV), sedation, Hemothorax, seizures, arrythmias Inclusion criteria: * Patient between 18 years to 80 years. * Patient to myocardial revascularization by sternotomy Exclusion criteria: * Patitient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze) * Emergency surgery * Ejecction Fraction less than 35% * Allergy to the local anesthesic. * Allergy to opioids * Patient in who will be technically impossible the application of the blockade Trial treatment: Intervention: These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus intercostal plane block, will be performed echo-guided puncture in the line anterior axillar with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1 ml (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus Control: These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion will be suspended of Fentanyl.. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus Expected sample size, enrollment and expected number of centers: Sample size = 44 Recruitment start date: 15 january of 2019 Recruitment end date: 15 July of 2019 Follow-up end date: Number of centers: 1 Statistical considerations: * Intention to treat analysis * The primary outcomes will be analyzed using

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Central Contacts