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Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT) (SERRINT)

Primary Purpose

Pain, Postoperative, Pain Management, Analgesia, Patient-Controlled

Status
Unknown status
Phase
Not Applicable
Locations
Colombia
Study Type
Interventional
Intervention
Bilateral serratus Intercostal plane Block
Sponsored by
Fundación Cardiovascular de Colombia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Postoperative focused on measuring Analgesia, patient- controlled, Block , Pain Postoperative

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Luz Jenny PachecoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Conventional Analgesia

Serrato intercostal plane Block

Arm 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.

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

Outcomes

Primary Outcome Measures

Fentanyl Consume
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative

Secondary Outcome Measures

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.
Nausea and vomiting
Presence of nausea and vomiting during the first 48 hours postoperative.
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.
hemothorax
presence of hemothorax secundary to blockage
seizures
presence of seizure after to blockage
Arrhythmias
presence of Arrhythmias after of blockage

Full Information

First Posted
January 9, 2019
Last Updated
August 20, 2019
Sponsor
Fundación Cardiovascular de Colombia
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1. Study Identification

Unique Protocol Identification Number
NCT03813225
Brief Title
Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)
Acronym
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 15, 2019 (Actual)
Primary Completion Date
August 30, 2019 (Anticipated)
Study Completion Date
September 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Cardiovascular de Colombia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Pain Management, Analgesia, Patient-Controlled, Nerve Block
Keywords
Analgesia, patient- controlled, Block , Pain Postoperative

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesia
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
Participant: The Patients will not know about intervention group they will be. Care Provider : The medical, nursing and pain clinical will not know the group to which the patient belongs Outcomes Assessor: during the analysis the staff will not know which group the patient belong
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional Analgesia
Arm Type
No Intervention
Arm 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.
Arm Title
Serrato intercostal plane Block
Arm Type
Experimental
Arm 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
Intervention Type
Other
Intervention Name(s)
Bilateral serratus Intercostal plane Block
Intervention Description
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.)
Primary Outcome Measure Information:
Title
Fentanyl Consume
Description
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Pain In Rest and in motion
Description
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.
Time Frame
48 hours
Title
Nausea and vomiting
Description
Presence of nausea and vomiting during the first 48 hours postoperative.
Time Frame
48 hours.
Title
Sedation
Description
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.
Time Frame
48 hours.
Title
hemothorax
Description
presence of hemothorax secundary to blockage
Time Frame
24 hours
Title
seizures
Description
presence of seizure after to blockage
Time Frame
1 hour after block
Title
Arrhythmias
Description
presence of Arrhythmias after of blockage
Time Frame
1 hour after block

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luz Pacheco, Esp
Phone
57 7 6396767
Ext
411
Email
luzjepal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Anderson Bernmon, MsC
Phone
57 7 6399292
Email
andebermon@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
luz Pacheco, Esp
Organizational Affiliation
Fundacion Cardiovascular
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luz Jenny Pacheco
City
Floridablanca
State/Province
Santander
ZIP/Postal Code
681004
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
luz Pacheco, Esp
Phone
57 7 6396767
Ext
411
Email
luzjepal@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

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