Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

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

Eligibility Criteria:
Inclusion Criteria:

* Patient between 18 years to 80 years
* Patient to myocardial revascularization by sternotomy

Exclusion Criteria:

* Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze)
* Emergency surgery
* Ejection Fraction less than 35%
* Allergy to the local anesthesics.
* Allergy to opioids
* Patient in who will be technically impossible the application of the blockade