NCT03813225

Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

Randomized Clinical Trial to Evaluate the Superiority on the Decrease the Consumption of Fentanyl the First 48 Hours of Bilateral Serratus Intercostal Plane Block in Myocardial Revascularization Surgery by Sternotomy.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Fundación Cardiovascular de Colombia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

• Pain, Postoperative
• Pain Management
• Analgesia, Patient-Controlled
• Nerve Block

Interventions

Type	Name	Description
OTHER	Bilateral serratus Intercostal plane Block	Will be performed by echo guided one puncture in the fifth costal arch with anterior axilary line, where the tip of the needle will be guided until it reaches a point above the external intercostal muscle, below the anterior serratus above the costal arch where they will be administered 21 ml of anesthesic mass, (20 ml of levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone.)

Timeline

• Start date: 2019-01-15
• Primary completion: 2019-08-30
• Completion: 2019-09-30
• First posted: 2019-01-23
• Last updated: 2019-08-22

Locations

1 site across 1 country: Colombia