Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI)
Key facts
- Who runs it
- Istanbul University - Cerrahpasa
- Where
- Türkiye1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Completed
- People taking part
- 50 people enrolled
- Started
- 28 Dec 2024
- Ended
- 2 Feb 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Ultrasound
- Local anesthesia and sedation
- Record updated
- 8 May 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 14 criteriaShow less
Who can take part
- TAVI procedures
- over 18 years of age
- elective procedures
- Signing the volunteer consent form
- Providing optimal images in ultrasound imaging
Who cannot take part
- 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
- Allergic to the prescribed medications
- < 18 yers of age
- emergency procedures
- morbidly obese patients (BMI>35kg/m2)
- Cannot be communicated and cannot be given a position
- Pregnants
- Those who refused to sign volunteer consent form
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Block groupExisting treatment, for comparison
Local anesthesia and sedation will be applied as standard procedure and unilateral USG-guided TAP block will be performed. In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target BIS value of 70-80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. In case of pain or patient movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol.
Treatment: Ultrasound and Local anesthesia and sedation
- Control groupSham treatment, for comparison
Local anesthesia and sedation will be administered according to standard procedure. In the control group a simulated TAP block procedure will be performed under ultrasound-guided conditions with injection of the same volume normal saline to maintain blinding; however, no local anesthetic will be administered (C) (n: 25). In both groups, all patients will receive 2 mg intravenous midazolam. Sedation will be achieved with dexmedetomidine at a rate of 0.2-0.7 µg/kg/h, to maintain a target BIS value of 70-80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. In case of pain or patient movement during the procedure, rescue analgesia will be administered as fentanyl (0.5 to 1 µg/kg). In the event of the patient experiencing discomfort due to inadequate analgesia, doses of ketamine and propofol with 1:1 ratio (0.20 to 0.25 mg/kg) will be administered as the rescue sedo-analgesia protocol.
Treatment: Ultrasound and Local anesthesia and sedation
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Analgesic Effectiveness Of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block In Transfemoral Transcatheter Aortic Valve Implantation (TAVI)
- Record updated
- 8 May 2026