Status:
RECRUITING
Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Queen Elizabeth II Health Sciences Centre
Foothills Medical Centre
Conditions:
Post-operative Pain
Post-operative Delirium
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 st...
Detailed 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. The primary outcome will...
Eligibility Criteria
Inclusion
- Adult patients undergoing cardiac surgery via median sternotomy
Exclusion
- 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
Key Trial Info
Start Date :
September 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
340 Patients enrolled
Trial Details
Trial ID
NCT06028126
Start Date
September 8 2023
End Date
January 1 2026
Last Update
November 28 2025
Active Locations (4)
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1
Foothills Medical Centre
Calgary, Alberta, Canada
2
Royal Columbian Hospital
Vancouver, British Columbia, Canada
3
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, NS B3H 3A7
4
St. Michael's Hospital
Toronto, Ontario, Canada, M5B 1W8