<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03813225</url>
  </required_header>
  <id_info>
    <org_study_id>fcv465</org_study_id>
    <nct_id>NCT03813225</nct_id>
  </id_info>
  <brief_title>Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)</brief_title>
  <acronym>SERRINT</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación Cardiovascular de Colombia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación Cardiovascular de Colombia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two-parallel arm, double-blind, individually randomized controlled trial.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      Fentanyl consumption in the first 48 postoperative hours.&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
      Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV),&#xD;
      sedation, Hemothorax, seizures, arrythmias&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.&#xD;
&#xD;
      Primary endpoint:&#xD;
&#xD;
      Fentanyl consumption in the first 48 postoperative hours.&#xD;
&#xD;
      Secondary endpoints:&#xD;
&#xD;
      Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV),&#xD;
      sedation, Hemothorax, seizures, arrythmias&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        -  Patient between 18 years to 80 years.&#xD;
&#xD;
        -  Patient to myocardial revascularization by sternotomy&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        -  Patitient for combined surgery ( myocardial revascularization by sternotomy plus valve&#xD;
           or maze)&#xD;
&#xD;
        -  Emergency surgery&#xD;
&#xD;
        -  Ejecction Fraction less than 35%&#xD;
&#xD;
        -  Allergy to the local anesthesic.&#xD;
&#xD;
        -  Allergy to opioids&#xD;
&#xD;
        -  Patient in who will be technically impossible the application of the blockade&#xD;
&#xD;
      Trial treatment:&#xD;
&#xD;
      Intervention: These patients will receive the protocol multimodal analgesia patients receive&#xD;
      on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg,&#xD;
      Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2&#xD;
      Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion&#xD;
      will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus&#xD;
      intercostal plane block, will be performed echo-guided puncture in the line anterior axillar&#xD;
      with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1&#xD;
      ml (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen&#xD;
      oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus&#xD;
&#xD;
      Control:&#xD;
&#xD;
      These patients will receive the protocol multimodal analgesia patients receive on the&#xD;
      Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl&#xD;
      Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h&#xD;
      during extracorporeal circulation , after extracorporeal circulation the infusion will be&#xD;
      suspended of Fentanyl.. and the postoperative analgesia will be 500mg of acetaminophen oral&#xD;
      and Analgesia, patient controlled with Fentanyl 20mcg/bolus&#xD;
&#xD;
      Expected sample size, enrollment and expected number of centers:&#xD;
&#xD;
      Sample size = 44 Recruitment start date: 15 january of 2019 Recruitment end date: 15 July of&#xD;
      2019&#xD;
&#xD;
      Follow-up end date:&#xD;
&#xD;
      Number of centers: 1&#xD;
&#xD;
      Statistical considerations:&#xD;
&#xD;
        -  Intention to treat analysis&#xD;
&#xD;
        -  The primary outcomes will be analyzed using&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 15, 2019</start_date>
  <completion_date type="Anticipated">September 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">August 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia&#xD;
Control:&#xD;
Usual multimodal analgesia</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <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</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Fentanyl Consume</measure>
    <time_frame>48 hours</time_frame>
    <description>Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain In Rest and in motion</measure>
    <time_frame>48 hours</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nausea and vomiting</measure>
    <time_frame>48 hours.</time_frame>
    <description>Presence of nausea and vomiting during the first 48 hours postoperative.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sedation</measure>
    <time_frame>48 hours.</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hemothorax</measure>
    <time_frame>24 hours</time_frame>
    <description>presence of hemothorax secundary to blockage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>seizures</measure>
    <time_frame>1 hour after block</time_frame>
    <description>presence of seizure after to blockage</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arrhythmias</measure>
    <time_frame>1 hour after block</time_frame>
    <description>presence of Arrhythmias after of blockage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Pain Management</condition>
  <condition>Analgesia, Patient-Controlled</condition>
  <condition>Nerve Block</condition>
  <arm_group>
    <arm_group_label>Conventional Analgesia</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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.&#xD;
and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Serrato intercostal plane Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bilateral serratus Intercostal plane Block</intervention_name>
    <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.)</description>
    <arm_group_label>Serrato intercostal plane Block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient between 18 years to 80 years&#xD;
&#xD;
          -  Patient to myocardial revascularization by sternotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient for combined surgery ( myocardial revascularization by sternotomy plus valve&#xD;
             or maze)&#xD;
&#xD;
          -  Emergency surgery&#xD;
&#xD;
          -  Ejection Fraction less than 35%&#xD;
&#xD;
          -  Allergy to the local anesthesics.&#xD;
&#xD;
          -  Allergy to opioids&#xD;
&#xD;
          -  Patient in who will be technically impossible the application of the blockade&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>luz Pacheco, Esp</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacion Cardiovascular</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luz Pacheco, Esp</last_name>
    <phone>57 7 6396767</phone>
    <phone_ext>411</phone_ext>
    <email>luzjepal@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anderson Bernmon, MsC</last_name>
    <phone>57 7 6399292</phone>
    <email>andebermon@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Luz Jenny Pacheco</name>
      <address>
        <city>Floridablanca</city>
        <state>Santander</state>
        <zip>681004</zip>
        <country>Colombia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>luz Pacheco, Esp</last_name>
      <phone>57 7 6396767</phone>
      <phone_ext>411</phone_ext>
      <email>luzjepal@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Colombia</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 20, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>August 20, 2019</last_update_submitted>
  <last_update_submitted_qc>August 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Analgesia, patient- controlled, Block , Pain Postoperative</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03813225
org study id: fcv465
nct id: NCT03813225
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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
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
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia
Control:
Usual multimodal analgesia
primary purpose: Supportive Care
masking: Triple (Participant, Care Provider, Outcomes 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
measure: Fentanyl Consume
time frame: 48 hours
description: Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
measure: Pain In Rest and in motion
time frame: 48 hours
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.
measure: Nausea and vomiting
time frame: 48 hours.
description: Presence of nausea and vomiting during the first 48 hours postoperative.
measure: Sedation
time frame: 48 hours.
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.
measure: hemothorax
time frame: 24 hours
description: presence of hemothorax secundary to blockage
measure: seizures
time frame: 1 hour after block
description: presence of seizure after to blockage
measure: Arrhythmias
time frame: 1 hour after block
description: presence of Arrhythmias after of blockage
arm group label: Conventional Analgesia
arm group type: No Intervention
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 group label: Serrato intercostal plane Block
arm group type: Experimental
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: Bilateral serratus Intercostal plane Block
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.)
arm group label: Serrato intercostal plane Block
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: luz Pacheco, Esp
role: Principal Investigator
affiliation: Fundacion Cardiovascular
last name: Luz Pacheco, Esp
phone: 57 7 6396767
phone ext: 411
email: luzjepal@gmail.com
last name: Anderson Bernmon, MsC
phone: 57 7 6399292
email: andebermon@gmail.com
facility: 
status: Recruiting
contact: 
country: Colombia
responsible party type: Sponsor
mesh term: Pain, Postoperative
sharing ipd: No