Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

Study Overview
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Brief Summary
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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
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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

Official Title
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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.

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

Intervention / Treatment
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* Other: Bilateral serratus Intercostal plane Block


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesia
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional Analgesia<br>These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation for handling an analgesic in cardiovascular surgery, this start in surgery 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. | |
| Experimental: Serrato intercostal plane Block<br>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 mg (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus | Other: Bilateral serratus Intercostal plane Block<br>* 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.)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl Consume | Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain In Rest and in motion | It will be valued the pain at rest and in motion, by means of the verbal analog scale for pain, where zero is the absence of pain and 10 is the worst pain that has had on the lives, the pain is measured from the time of extubation what we will call zero hour, and every four hours per 48 hours. | 48 hours | 
| Nausea and vomiting | Presence of nausea and vomiting during the first 48 hours postoperative. | 48 hours. | 
| Sedation | Assessment of sedation in the first 48 hours postoperative with the Ramsay scale .The Ramsay scale , Is a subjective scale to assess the degree of sedation of patients, values 6 levels, from 1 where the patient is anxious and agitated ,2 Awake, coperador, focused and quiet. 3. Slept with response to orders. 4. Sleepy with brief answers to the Light. 5 is patient Slept with an answer only to the pain and 6 where the patient is deep asleep without response to stimuli. | 48 hours. | 
| hemothorax | presence of hemothorax secundary to blockage | 24 hours | 
| seizures | presence of seizure after to blockage | 1 hour after block | 
| Arrhythmias | presence of Arrhythmias after of blockage | 1 hour after block | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia, patient- controlled, Block , Pain Postoperative