Skip to main content
OpenTrials
Completed

NCT Number: NCT03734159

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Bypass Graft Stenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

CMC Ambroise Paré

Neuilly-sur-Seine, Île-de-France Region, 92200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ropivacaine

Drug

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)

Sodium chloride 0.9%

Drug

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

CMC Ambroise Paré

Other

Registry information

Official study 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

Acronym: PARA

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 7, 2018
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.