Pain management during transcatheter aortic valve implantation using TAP block
Analgesic Effectiveness Of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block In Transcatheter Aortic Valve Implantation (TAVI)
This study is testing if a special pain management technique called TAP block can make patients more comfortable during a heart valve procedure and improve their overall experience compared to standard anesthesia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06762288 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of ultrasound-guided transversus abdominis plane (TAP) block for pain management during transcatheter aortic valve implantation (TAVI). The goal is to enhance hemodynamic stability and reduce complications by minimizing patient movement due to pain. Participants will be randomly assigned to receive either the TAP block or standard local anesthesia and sedation. The study aims to evaluate the impact of TAP block on patient and physician satisfaction, as well as the overall quality of healthcare provided during the procedure.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old undergoing elective TAVI procedures with a stable INR.
Not a fit: Patients who are morbidly obese, under 18, or have advanced heart failure may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain management and procedural outcomes for patients undergoing TAVI.
How similar studies have performed: While TAP block has been studied in other contexts, this specific application in TAVI procedures is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * TAVI procedures * over 18 years of age * INR \< 1,5 * elective procedures * Signing the volunteer consent form * Providing optimal images in ultrasound imaging Exclusion Criteria: * \< 18 yers of age * emergency procedures * morbidly obese patients (BMI\>35kg/m2) * Advanced decompensated heart failure with New york Heart Association (NYHA) stage 4 * Those who have skin infection, lesion, hematoma in the area to be blocked * Cannot be communicated and cannot be given a position * Allergic to the prescribed medications * Pregnants * Those who refused to sign volunteer consent form
Where this trial is running
Istanbul
- Istanbul University-Cerrahpaşa — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Ayla Esin
- Email: ayla.esin@iuc.edu.tr
- Phone: +905326343959
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.