Intrapleural ropivacaine after heart surgery
Intrapleural Ropivacaine Infusion in Cardiac Surgery: Randomized Double-blind Controlled Study
PHASE4 · Saint Petersburg State University, Russia · NCT07116343
This study will test whether putting ropivacaine into the pleural space through chest drains reduces pain and improves recovery for adults after heart surgery.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Saint Petersburg State University, Russia (other) |
| Locations | 2 sites (Saint Petersburg and 1 other locations) |
| Trial ID | NCT07116343 on ClinicalTrials.gov |
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 4 trial comparing intrapleural ropivacaine infusion to saline in adults having cardiac surgery with planned opening of the pleural cavities. After median sternotomy and placement of pleural drains, participants receive either ropivacaine or 0.9% NaCl through the drains for the early postoperative period. Outcomes include postoperative pain, opioid consumption, quality of recovery, and safety/complications related to the local anesthetic. The trial is conducted at university and regional hospital sites in Russia.
Who should consider this trial
Good fit: Adults (over 18) scheduled for cardiac surgery via median sternotomy with planned pleural opening who can give informed consent and have no contraindication to ropivacaine are ideal candidates.
Not a fit: Patients who are undergoing redo cardiac surgery, those with contraindications to ropivacaine, or patients who do not have pleural drains are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, patients could experience less chest pain, lower opioid needs, and a faster recovery after heart surgery.
How similar studies have performed: Prior intrapleural anesthetic use after thoracic surgery has shown safety and reduced pain, though evidence specifically in cardiac surgery is more limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Scheduled cardiac surgery using a standard median sternotomy. * Planned opening of the pleural cavities. * Age more than 18 years. * Signed informed consent to participate in the study. Exclusion Criteria: * Contraindications for ropivacaine * Redo surgery
Where this trial is running
Saint Petersburg and 1 other locations
- Saint-Petersburg university hospital — Saint Petersburg, Russia (RECRUITING)
- Primorskiy general hospital #1 — Vladivostok, Russia (RECRUITING)
Study contacts
- Study coordinator: Sergey M Efremov, MD, PhD
- Email: efremovsergm@gmail.com
- Phone: 79137946090
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.
Conditions: Cardiac Surgery, Coronary Artery Disease, Valvular Diseases, cardiac surgery, quality of recovery, ropivacaine, postoperative analgesia