Using paravertebral blocks to improve recovery after heart surgery
Bilateral Paravertebral Blockade for Improvement of Quality of Recovery Following Cardiac Surgery (P-QOR): a Randomized Controlled Trial
This study is testing if a specific type of pain relief technique can help people recover better after heart surgery compared to a placebo treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 224 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Trial ID | NCT06008821 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of bilateral paravertebral blockade compared to sham blocks in enhancing recovery quality following cardiac surgery. It is a triple-blinded, randomized, single-centered, placebo-controlled trial where patients will be assigned to either the intervention or control group. The primary outcome is to measure the Quality of Recovery-15 score at 24 hours post-surgery, while secondary outcomes include pain scores, opioid use, respiratory mechanics, and sleep quality in the first 24-48 hours. The study aims to provide insights into the benefits of regional anesthesia in cardiac surgical patients.
Who should consider this trial
Good fit: Ideal candidates are English-speaking adults aged 19 and older scheduled for elective cardiac surgery involving full median sternotomy.
Not a fit: Patients who may not benefit include those with significant cognitive impairment, emergent surgery needs, or contraindications such as infection at the injection site or severe spinal deformities.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery quality and reduce post-operative pain for patients undergoing cardiac surgery.
How similar studies have performed: Other studies have shown promising results with regional anesthesia techniques in improving recovery outcomes, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * All adult (19 years or older) * English-speaking patients * Scheduled for elective cardiac surgery with full median sternotomy. Exclusion Criteria * Patient refusal, inability to provide consent * Mini-Cog© Score of 1-2 * emergent surgery * infection at the site of injection * empyema * neoplastic mass in the paravertebral space * known preoperative coagulopathy * platelet count \< 50 x 109, INR or aPTT exceeding the upper range of normal in the absence of anticoagulant use, patients receiving anticoagulation medications or non-ASA anti-platelet medications that have not been stopped for the appropriate duration in accordance with American Society of Regional Anesthesia and Pain Medicine guidelines (20) * severe kyphoscoliosis or deformed spines or previous thoracic surgery * allergy to study medications * preoperative liver failure (as defined by Child-Pugh B or C) * chronic pain or opioid use history, alcohol or drug use disorders, major psychiatric or neurodevelopmental disorders * Moderate to severe pain at baseline. * preoperative renal failure (as defined by eGFR \< 30 mL/min/1.73 m2) * extremes of weight (BMI \> 40 kg/m2, and weight \< 50 kg) * Patients anticipated to require prolonged post-operative ventilation \> 24 hours after surgery * High risk by Euroscore II \>=8%) (21-23) * 3 or more major procedures * Procedures requiring deep hypothermic circulatory arrest (DHCA)
Where this trial is running
Vancouver, British Columbia
- St. Paul's Hospital — Vancouver, British Columbia, Canada (Recruiting)
Study contacts
- Principal investigator: Terri Sun, M.D. — University of British Columbia
- Study coordinator: Terri Sun, M.D.
- Email: terri.sun@gmail.com
- Phone: 604-779-7817
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.