Reducing opioid use after cardiac surgery with a specific nerve block technique
Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial
This study is testing if a specific nerve block technique can help patients after heart surgery use less opioid pain medication and manage their pain better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Unity Health Toronto Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06028126 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of intermittent superficial parasternal intercostal plane blocks in reducing opioid consumption in patients undergoing cardiac surgery with median sternotomy. Participants will be randomly assigned to receive either 0.2% ropivacaine or a saline placebo through catheters placed in the intercostal plane under ultrasound guidance. The primary outcomes measured will include cumulative postoperative opioid use, pain scores at rest and during coughing, and the incidence of postoperative delirium over a 72-hour period. The study seeks to determine if the nerve block can lead to better pain management and reduced reliance on opioids post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adult patients undergoing cardiac surgery via median sternotomy.
Not a fit: Patients who have chronic opioid use for more than six weeks or those undergoing non-sternotomy cardiac procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly decrease opioid use and improve pain management for patients after cardiac surgery.
How similar studies have performed: Other studies have shown promise with similar nerve block techniques in reducing opioid use, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Toronto, Ontario
- St. Michael's Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Ahmad Alli, MD — Unity Health Toronto
- Study coordinator: Adrian Quan, M.Phil.
- Email: adrian.quan@unityhealth.to
- Phone: 416-864-6060
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.