Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

Pain, Postoperative Clinical Trial

— SERRINT  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03813225
• Other study ID #: fcv465
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: September 30, 2019

Study information

• Verified date: August 2019
• Source: Fundación Cardiovascular de Colombia
• Contact: Luz Pacheco, Esp
• Phone: 57 7 6396767
• Email: luzjepal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: September 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.)

Locations

Country	Name	City	State
Colombia	Luz Jenny Pacheco	Floridablanca	Santander

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Cardiovascular de Colombia

Country where clinical trial is conducted

Colombia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fentanyl Consume	Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative	48 hours
Secondary	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
Secondary	Nausea and vomiting	Presence of nausea and vomiting during the first 48 hours postoperative.	48 hours.
Secondary	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.
Secondary	hemothorax	presence of hemothorax secundary to blockage	24 hours
Secondary	seizures	presence of seizure after to blockage	1 hour after block
Secondary	Arrhythmias	presence of Arrhythmias after of blockage	1 hour after block