Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI) (NCT06762288) | Clinical Trial Compass
CompletedNot Applicable
Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI)
Turkey (Türkiye)50 participantsStarted 2024-12-28
Plain-language summary
Hemodynamic stability is the main goal of the anesthetic method during Transcatheter Aortic Valve Implantation (TAVI). Pain during the procedure may cause patients to move therefore hemodynamic instability. This may lead to undesirable complications for the patient and the physician. At the same time, it may affect the process quality and cause the processing time to be extended. In this prospective-randomised clinical trial, ultrasound-guided transversus abdominis plan block will be performed to reduce pain. We aimed to contribute to the reduction of undesirable outcomes for the patient and physician by providing adequate anesthesia with Transversus Abdominis Plan (TAP) block accompanied by sedation, and to present its impact on the quality of the healthcare service provided by evaluating patient and physician satisfaction.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* TAVI procedures
* over 18 years of age
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The pain assessed by the Numeric Rating Scale-11 (NRS-11) to measure the analgesic efficacy of TAP
Timeframe: From procedure start to 4 hours post-procedure, assessed at four time points: femoral sheath insertion, intraprocedural valve positioning, femoral sheath removal, and sandbag compression at 4 hours post-procedure.