Clinical trial NCT03813225: Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain, Postoperative
Pain Management
Analgesia, Patient-Controlled
Nerve Block
Keywords: Analgesia, patient- controlled, Block , Pain Postoperative
Lead sponsor: Fundación Cardiovascular de Colombia
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia

Control:

Usual multimodal analgesia
Primary purpose: SUPPORTIVE_CARE

Brief 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

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

Primary outcomes:
measure: Fentanyl Consume
timeFrame: 48 hours
Secondary outcomes:
measure: Pain In Rest and in motion
timeFrame: 48 hours
measure: Nausea and vomiting
timeFrame: 48 hours.
measure: Sedation
timeFrame: 48 hours.
measure: hemothorax
timeFrame: 24 hours
measure: seizures
timeFrame: 1 hour after block
measure: Arrhythmias
timeFrame: 1 hour after block
Other outcomes:
Locations:
city: Floridablanca
country: Colombia
facility: Luz Jenny Pacheco
state: Santander
Study officials:
affiliation: Fundacion Cardiovascular
name: luz Pacheco, Esp
role: PRINCIPAL_INVESTIGATOR
References: