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The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery (PARA)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03734159
Recruitment Status : Completed
First Posted : November 7, 2018
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
CMC Ambroise Paré

Brief Summary:

Patients undergoing coronary artery bypass grafting are at risk for perioperative myocardial ischemia. Episodes of tachycardia and hypertension, which are associated with an increase in myocardial oxygen consumption, are predictive events of these ischemia.

During cardiac surgery by sternotomy, some maneuvers, e.g. intubation, skin incision, sternotomy and cannulation, may be associated with tachycardia and/or increases in blood pressure despite an adequate level of anesthesia. Usually these episodes are controlled by the administration of a high-dose of anesthetic agents.

The parasternal block, by bolus or continuous infusion through a single catheter, showed its effectiveness on postoperative pain after sternotomy. It allows a blocking of anterior branches of intercostal nerves at the lateral edge of the sternum; branches in charge of innervation of the sternum and the overlying skin surface.

The preoperative parasternal block, once general anesthesia performed, could provide an effective level of locoregional anesthesia of the chest wall, thus limiting the occurrence of episodes of tachycardia and / or hypertension without having to resort to massive doses of anesthetic agents during sternotomy in patients undergoing coronary bypass surgery.


Condition or disease Intervention/treatment Phase
Coronary Bypass Graft Stenosis Drug: Ropivacaine Drug: sodium chloride 0.9% Phase 4

Detailed Description:

This randomized double blinded placebo-controlled clinical trial will include patients undergoing coronary artery bypass grafting.

Locoregional anesthesia of the chest wall will be performed under ultrasound, once general anesthesia performed. A total volume of 60 ml of sodium chloride 0.9% (placebo group) or ropivacaine 0.25% (experimental group) divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5) will be injected.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Interest of Parasternal Block to Limit the Doses of Anesthetics Necessary for the Maintenance of Arterial Blood Pressure and Heart Rate in the Recommended Values During Sternotomy in Patients Undergoing Coronary Artery Bypass Graft
Actual Study Start Date : December 13, 2018
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : November 7, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: parasternal block
preoperative parasternal block by ropivacaine injection
Drug: Ropivacaine
Injection of 60 ml of ropivacaine 0.25% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)

Placebo Comparator: physiological serum
sodium chloride injection
Drug: sodium chloride 0.9%
Injection of 60 ml of sodium chloride 0.9% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)




Primary Outcome Measures :
  1. Show that the preoperative realization of a parasternal block limites the posology of remifentanil administered during sternotomies to maintain blood pressure and heart rate within recommended ranges [ Time Frame: Intraoperative period : from intubation to sternal retractor setup ]
    Maximal dose of remifentanil (morphine peak) required to maintain hemodynamic parameters (arterial blood pressure and heart rate) in the appropriate values during intubation, skin incision, sternotomy and sternal retractor setup


Secondary Outcome Measures :
  1. Hemodynamic response : heart rate [ Time Frame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup ]
    Measure of heart rate in bpm

  2. Hemodynamic response : arterial blood pressure [ Time Frame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup ]
    Measure of diastolic and systolic arterial blood pressure in mmHg

  3. Hemodynamic response : patient state index [ Time Frame: Intraoperative period : from the start of general anesthesia maintenance to the fifth minute after sternal retractor setup ]
    Measure of patient state index ranging from 0 to 100 (0=very deep anesthesia, 100=no hypnotic state)

  4. Dose of hypnotic drug [ Time Frame: Intraoperative period : from induction of anesthesia to skin closure ]
    Total amount of propofol administered during surgery

  5. Dose of analgesic drug [ Time Frame: Intraoperative period : from induction of anesthesia to skin closure ]
    Total amount of remifentanil administered during surgery

  6. Inflammatory response [ Time Frame: 7 days ]
    Serum concentrations of cytokines in pg/ml (composite : pro- (IL-6, IL-8, IL-1β, TNF-α, IFN-γ) and anti-inflammatory (IL-10) cytokines)

  7. Pain level during extubation: Numeric scale [ Time Frame: 8 hours ]
    Numeric scale of pain, ranging from 0 to 10 (0 = no pain, 10= worst possible pain)

  8. Complications [ Time Frame: 7 days ]
    Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension



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 coronary artery bypass graft requiring sternotomy other than re-interventions and combined surgeries
  • Consent for participation
  • Affiliation to the french social security system

Exclusion Criteria:

  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curator or safeguard of justice)
  • Communication difficulties or neuropsychiatric disorder
  • Neuropathic disease
  • Constitutional coagulation disorders
  • Kidney insufficiency
  • Sensitivity to nonsteroidal anti-inflammatory drugs
  • Hypersensitivity to local anaesthetics
  • Chronic use of opioid analgesics
  • Corticosteroid treatment or immunosuppressive therapy
  • Autoimmune disease
  • Chronic pain syndrome or fibromyalgia
  • Emergency cardiac surgery
  • Hypovolemia

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): NCT03734159


Locations
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France
CMC Ambroise Paré
Neuilly-sur-Seine, Ile-de-France, France, 92200
Sponsors and Collaborators
CMC Ambroise Paré
Investigators
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Principal Investigator: Sébastien Bloc, MD CMC Ambroise Paré
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Responsible Party: CMC Ambroise Paré
ClinicalTrials.gov Identifier: NCT03734159    
Other Study ID Numbers: 2018/07
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: December 2018
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
Keywords provided by CMC Ambroise Paré:
Regional Anesthesia
Sternotomy
Additional relevant MeSH terms:
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Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents