Cryoablation of intercostal nerves to manage pain after minimally invasive mitral valve surgery
Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery: a Pilot Prospective Randomized Study
This study is testing if freezing certain nerves can help reduce pain and the need for pain medication in patients after minimally invasive heart valve surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Meshalkin Research Institute of Pathology of Circulation Research network |
| Locations | 1 site (Novosibirsk) |
| Trial ID | NCT06443931 on ClinicalTrials.gov |
What this trial studies
This pilot clinical trial aims to evaluate the effectiveness of cryoablation of intercostal nerves in reducing pain and opioid consumption in patients undergoing minimally invasive mitral valve surgery. The study is designed as a single-center, prospective, randomized trial with a 1:1 allocation ratio. Participants will be monitored for pain levels using the Visual Analog Scale (VAS) and for their opioid analgesic consumption post-surgery. The findings will provide preliminary data to inform a larger future trial.
Who should consider this trial
Good fit: Ideal candidates for this study are patients scheduled for minimally invasive mitral valve surgery who can provide informed consent.
Not a fit: Patients who are pregnant, have chronic pain conditions, or are on certain medications that affect pain perception may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce postoperative pain and reliance on opioid medications for patients undergoing minimally invasive mitral valve surgery.
How similar studies have performed: While this approach is innovative, similar studies on nerve cryoablation for pain management have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Written informed consent; * Minimally invasive mitral valve surgery. Non-inclusion criteria: * patient refusal; * pregnancy; * treatment with antidepressants or epileptic drugs; * depression, which can significantly affect the perception of pain; * chronic use of analgesics; * participation in competing randomized clinical trials. Exclusion criteria: - Extended mechanical ventilation, more than 12 hours.
Where this trial is running
Novosibirsk
- Meshalkin Research Institute of Pathology of Circulation — Novosibirsk, Russian Federation (Recruiting)
Study contacts
- Study coordinator: Gleb Moroz, PHD
- Email: Glebmorozz@gmail.com
- Phone: 347 60 54
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.