Comparing two pain management techniques for patients undergoing heart valve replacement
Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management - A Randomized, Prospective Study
NA · Medipol University · NCT06773780
This study is testing two different pain relief methods for patients having heart valve replacement surgery to see which one helps them feel better after the procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Medipol University (other) |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06773780 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two different analgesic techniques, the Pericapsular Nerve Group Block (PENG) and the Fascia Iliaca Block (FIB), in managing postoperative pain for patients undergoing Transcatheter Aortic Valve Implantation (TAVI). The study aims to determine which method provides better pain relief without motor block, thereby improving recovery outcomes for patients with aortic stenosis. Participants will be selected based on specific criteria, including age and physical health status, and will be monitored for pain management effectiveness post-procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 18 to 85 scheduled for TAVI with an ASA physical status of II-IV.
Not a fit: Patients with a history of bleeding disorders, chronic pain, or those unable to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved postoperative pain management for patients undergoing TAVI, enhancing their recovery experience.
How similar studies have performed: Other studies have shown promising results with similar analgesic techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients scheduled for TAVİ * aged between 18 and 85 years, * American Society of Anesthesiology (ASA) physical status II-IV Exclusion Criteria: * History of bleeding diathesis. * Use of anticoagulant therapy. * History of chronic pain prior to surgery. * Multiple trauma. * Conditions where pain assessment cannot be performed (e.g., dementia). * Patients operated under spinal or epidural anesthesia. * Presence of infection in the region where the block will be applied. * Refusal to consent to the procedure
Where this trial is running
Istanbul
- Medipol University — Istanbul, Turkey (Türkiye) (RECRUITING)
Study contacts
- Study coordinator: Burak Ömür
- Email: bomur@medipol.edu.tr
- Phone: +905056215056
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: Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Pericapsular Nerve Group Block, Fascia Iliaca Block