An interventional study of Ultrasound and Local anesthesia and sedation in Anesthesia, Analgesia and Block, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-08.
Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Treatment
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.
While common aortic valve stenosis was previously treated with surgical aortic valve replacement, with the developments in the field of interventional cardiology, Transcatheter Aortic Valve Implantation (TAVI) has emerged as an alternative to surgery in recent years and has become the first choice in the treatment of inoperable patients with severe aortic stenosis. Especially patients who are elderly, have chronic illnesses, have a high surgical risk, and whose general health condition is not suitable for surgery can be treated with this method.
Mostly the femoral artery is preferred for TAVI access because it has a large lumen (8-9 mm) and has less anatomical variation. After the inguinal ligament, the iliac artery, originating from the abdominal aorta, is called the femoral artery. Since this region is safe, it is preferred in cardiac interventions.
Transversus abdominis plane (TAP) block aims to block the ilioinguinal and iliohypogastric nerves which contribute to the sensory innervation of the femoral region used for endovascular cardiac interventions. No studies have been found on the analgesic efficacy of TAP block in TAVI procedures.
Local anesthesia and sedation as standard procedure will be applied to the control group (SCG) (n: 25). In TAP block group (TAPG) (n:25) standard procedure and unilateral ultrasound (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 Bispectral index (BIS) between 70 and 80. Before the start of the procedure, 50 µg intravenous fentanyl will be administered to all patients. If patients experience pain or 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. All medications will be recorded.
Patients' demographic data, hemodynamic parameters, total anesthetic drug consumption, procedure duration, complications seen during the procedure will be recorded. The pain level felt during procedure from valve positioning to deployment, when placing and withdrawing sheath and during sandbag compression at 4th postoperative hour will be recorded according to the Numeric rating scale-11 (NRS-11) scoring system. 5-point Likert scale will be used for patient and physician satisfaction.
Cardiac endovascular catheterization procedures such as TAVI are often anxiety-provoking and uncomfortable for patients. The anesthesia method may vary depending on the experience of the cardiology team, the characteristics of the patients and the procedure to be performed. In TAVI procedures, which were initially performed under general anesthesia, a combination of local anesthesia and sedation was preferred as the team's experience developed. Hemodynamic stability and patient immobilization are the main goals of the anesthetic method during TAVI. Due to pain, patients may develop hemodynamic instability and may move. This is an undesirable situation for cardiac patients. It may affect the quality of the procedure for the cardiologist and may cause complications and longer procedure times. Examining the effectiveness of anesthesia by applying TAP block accompanied by sedation and physician and patient satisfaction during and after the procedure forms the basis of the research. First aim of the study is to demonstrate the analgesic effectiveness of ultrasound-guided TAP block application in the femoral region before the procedure in 50 patients who underwent TAVI. Secondary aims are to reduce the need for anesthetic- analgesic drugs and to investigate patient and physician satisfaction and to investigate the incidence of unexpected patient movements.
1,190 studies on the registry are indexed under Agnosia; 508 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 1,024 interventional studies indexed under Agnosia.
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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.
Device: Ultrasound · Procedure: Local anesthesia and sedation
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.
Device: Ultrasound · Procedure: Local anesthesia and sedation
Sedation and local anesthesia to the surgical field will be applied as standard procedure and unilateral USG-guided TAP block will be performed to the patients who will undergo TAVİ.
Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.
The pain assessed by the Numeric Rating Scale-11 (NRS-11) to measure the analgesic efficacy of TAP
NRS is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable assessed at four perioperative time points.
Time frame: 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.
Total intraprocedural opioid consumption
Total fentanyl administered(mcg)
Time frame: from induction to end of procedure
Incidence of rescue sedo-analgesia requirement
proportion of patients requiring ketamine+ propofol ((1:1 ratio, 0.20-0.25 mg/kg) rescue sedo-analgesia due to inadequate pain control.
Time frame: from induction to end of procedure
incidence of sedation-related complications
proportion of patients experiencing any of the following: hypotension (systolic BP\<90mmHg), bradycardia (HR\<50bpm), oxygen desaturation (SpO2\<90%), apnea. Record as composite binary outcome (yes/no)
Time frame: from induction to 60 minutes post-procedure
unexpected patient movement
Score using Togawa et al. movement scoring system (0-3). ranging from 0 (no movement) to 3 (uncontrollable movement interfering with the procedure). For analysis, scores of 0, and 1 were categorized as "acceptable" while scores of 2, and 3 were deemed "unacceptable"
Time frame: during procedure
patient satisfaction
Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)
Time frame: 1 hour after end of procedure
physician satisfaction
Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)
Time frame: 1 hour after end of procedure
Plan to share: No
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Istanbul University - Cerrahpasa