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

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

Tracking Information

• First Submitted Date: November 5, 2018
• First Posted Date: November 7, 2018
• Last Update Posted Date: July 7, 2020
• Actual Study Start Date: December 13, 2018
• Actual Primary Completion Date: June 21, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 6, 2018)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 3, 2020)

• 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
• 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
• 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)
• Dose of hypnotic drug [ Time Frame: Intraoperative period : from induction of anesthesia to skin closure ]
  Total amount of propofol administered during surgery
• Dose of analgesic drug [ Time Frame: Intraoperative period : from induction of anesthesia to skin closure ]
  Total amount of remifentanil administered during surgery
• 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)
• 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)
• Complications [ Time Frame: 7 days ]
  Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension

Original Secondary Outcome Measures (submitted: November 6, 2018)

• 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
• 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
• Dose of hypnotic drug [ Time Frame: Intraoperative period : from induction of anesthesia to skin closure ]
  Total amount of propofol administered during surgery
• Dose of analgesic drug [ Time Frame: Intraoperative period : from induction of anesthesia to skin closure ]
  Total amount of remifentanil administered during surgery
• 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)
• 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)
• Complications [ Time Frame: 7 days ]
  Incidence of acute respiratory distress syndrome, pneumopathy, kidney failure or hypertension

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Benefit of Local Anesthesia at the Sternum in Patients With Coronary Surgery
• 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

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.

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.

• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Prevention
• Condition: Coronary Bypass Graft Stenosis

Intervention

• 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)
• 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)

Study Arms

• Experimental: parasternal block
  preoperative parasternal block by ropivacaine injection
  Intervention: Drug: Ropivacaine
• Placebo Comparator: physiological serum
  sodium chloride injection
  Intervention: Drug: sodium chloride 0.9%

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 29, 2019): 35
• Original Estimated Enrollment (submitted: November 6, 2018): 30
• Actual Study Completion Date: November 7, 2019
• Actual Primary Completion Date: June 21, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT03734159
• Other Study ID Numbers: 2018/07
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: CMC Ambroise Paré
• Study Sponsor: CMC Ambroise Paré
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sébastien Bloc, MD; CMC Ambroise Paré

• PRS Account: CMC Ambroise Paré
• Verification Date: December 2018