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Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Recruiting
18 years and older
All
Phase N/A

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Overview

The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy.

Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

Description

This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:

  1. cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME)
  2. median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion
  3. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

Eligibility

Inclusion Criteria:

  • Adult patients undergoing cardiac surgery via median sternotomy

Exclusion Criteria:

  • Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
  • Emergency procedures (surgery within 2 hours)
  • Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
  • Weight < 50kg
  • Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
  • Surgery for infective endocarditis
  • Pregnancy or nursing
  • Chronic opioid/narcotic use > 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes
  • Allergies to amide anesthetic agents or any components of study interventions
  • Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.)
  • Receipt of an investigational drug or device within past 7 days

Study details
    Post-operative Pain
    Post-operative Delirium
    Post-cardiac Surgery
    Chronic Pain
    Opioid Use Disorder
    Anesthesia
    Local

NCT06028126

Unity Health Toronto

30 January 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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