Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
CompletedNot applicableNCT06028126
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Brief summary (from the registry)
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.
Study details
- Official title
- Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial
- Conditions
- Post-operative Pain
- Post-operative Delirium
- Post-cardiac Surgery
- Chronic Pain
- Opioid Use Disorder
- Anesthesia, Local
- Interventions
- Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental
- Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Placebo
- Sponsor
- Unity Health Toronto
- Collaborators
- Queen Elizabeth II Health Sciences Centre; Foothills Medical Centre; Royal Columbian Hospital Foundation
- Start date
- 2023-09-08
- Primary completion
- 2026-01-06
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 4
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Canadian sites (4)
| Facility | City | Province |
|---|---|---|
| Foothills Medical Centre | Calgary | Alberta |
| Royal Columbian Hospital | Vancouver | British Columbia |
| QEII Health Sciences Centre | Halifax | Nova Scotia |
| St. Michael's Hospital | Toronto | Ontario |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT06028126