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Parasternal Block for Cardiac Surgery (Parasternal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04319588
Recruitment Status : Recruiting
First Posted : March 24, 2020
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Giulia Nonnis, Campus Bio-Medico University

Brief Summary:
This study examine the effect of Parasternal Intercostal Nerve Blocks with local anesthetic on pain control in patients undergoing non-emergent cardiac surgery in a prospective controlled trial. Half of participants will receive General Anesthesia combined to parasternal block while the other half receive only General Anesthesia.

Condition or disease Intervention/treatment Phase
Cardiac Disease Analgesia Acute Pain Postoperative Pain Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage Procedure: Infiltration with local anesthetic of access to thoracic drainage Not Applicable

Detailed Description:

60 patients undergoing elective cardiac surgery will be enrolled and divided into two groups:

  1. Interventional (parasternal group)
  2. Case control group The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.

The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Parasternal Block for Postoperative Analgesia in Cardiac Surgery: a Pilot Controlled Trial
Actual Study Start Date : March 6, 2020
Estimated Primary Completion Date : May 9, 2020
Estimated Study Completion Date : May 19, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Surgery

Arm Intervention/treatment
Experimental: Parasternal Group
The "parasternal group" of patients will receive the pre-operative parasternal block (20 ml of 0.5% Ropivacaine per side) in association with infiltration with local anesthetic of access to thoracic drainage (drainage infiltration with 20 ml of 0.25% Ropivacaine) at the end of the intervention combined to General Anesthesia.
Procedure: Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage
After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.

Active Comparator: Case control group
The "case control group" will only receive drainage infiltration with local anesthetic and standard intraoperative management with opioids.
Procedure: Infiltration with local anesthetic of access to thoracic drainage
Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.




Primary Outcome Measures :
  1. Maximum Pain Score [ Time Frame: 24 hours ]
    Postoperative pain assessment using the NRS scale (score from 0 to 10)

  2. Total opioids consumption [ Time Frame: 24 hours ]
    Number of opioid deliveries (bolus morphine) in the postoperative period

  3. Time to first opioid [ Time Frame: 48 hours ]
    The time in minutes between awakening and the first opioid administration


Secondary Outcome Measures :
  1. Respiratory performance at the TRI-FLOW [ Time Frame: 24 hours ]
    Respiratory performance is assessed by the number of balls raised during inspiration with the TRI-FLOW

  2. Intraoperative opioid administration [ Time Frame: 4 hours ]
    Quantitative evaluation of opioids needed in the intraoperative period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients undergoing elective cardiac surgery
  • Age over 18 years
  • ASA I-IV
  • Approval by the patient of informed consent

Exclusion Criteria:

  • Allergy to local anesthetics
  • Puncture site infection
  • Lack of signing of informed consent
  • Weight <30 Kg
  • Age <18 years
  • Emergency interventions
  • ASA > IV
  • Sternal dehiscences
  • Dementia (for difficulties in managing weaning from mechanical ventilation and pain)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04319588


Contacts
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Contact: Giulia Nonnis 3382752818 g.nonnis@unicampus.it

Locations
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Italy
Campus Biomedico University Recruiting
Rome, Roma, Italy, 00128
Contact: Giulia Nonnis, MD    3382752818    g.nonnis@unicampus.it   
Sponsors and Collaborators
Campus Bio-Medico University
Publications of Results:
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Responsible Party: Giulia Nonnis, Principal Investigator, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT04319588    
Other Study ID Numbers: 20/20 PAR ComEt CBM
First Posted: March 24, 2020    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Heart Diseases
Acute Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Cardiovascular Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents