Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

Fundación Cardiovascular de Colombia

Status: Unknown

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

Treatments: Other: Bilateral serratus Intercostal plane Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03813225

fcv465

Details and patient eligibility

About

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

Full 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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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44 participants in 2 patient groups

Conventional Analgesia

No Intervention group

Description:

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.

Serrato intercostal plane Block

Experimental group

Description:

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

Treatment:

Other: Bilateral serratus Intercostal plane Block