Transversus Abdominis Plan (TAP) Block for Transcatheter Aortic Valve Implantation (TAVI)

Analgesic Effectiveness Of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block In Transfemoral Transcatheter Aortic Valve Implantation (TAVI)

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.

Study Overview

• Status: Completed
• Conditions: Analgesia; Aortic Valve Stenosis; Anesthesia; Block
• Intervention / Treatment: Device: Ultrasound; Procedure: Local anesthesia and sedation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • İstanbul University-Cerrahpaşa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Block group; 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; 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.; Procedure: Local anesthesia and sedation; Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.
Sham Comparator: Control group; 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; 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.; Procedure: Local anesthesia and sedation; Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraprocedural opioid consumption	Total fentanyl administered(mcg)	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.	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)	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"	during procedure
patient satisfaction	Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)	1 hour after end of procedure
physician satisfaction	Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)	1 hour after end of procedure

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Study Chair: Kerem Erkalp, professor, Istanbul University - Cerrahpasa

Study record dates

Study Major Dates

• Study Start (Actual): December 28, 2024
• Primary Completion (Actual): February 2, 2026
• Study Completion (Actual): February 2, 2026

Study Registration Dates

• First Submitted: January 1, 2025
• First Submitted That Met QC Criteria: January 1, 2025
• First Posted (Actual): January 7, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; ultrasound; nerve block; aortic stenosis; transcatheter aortic valve implantation; interventional cardiology; transversus abdominis plan block; tavi
• Additional Relevant MeSH Terms: Aortic Valve Disease; Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Wounds and Injuries; Heart Diseases; Neurobehavioral Manifestations; Chemically-Induced Disorders; Heart Valve Diseases; Ventricular Outflow Obstruction; Poisoning; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Aortic Valve Stenosis; Bites and Stings; Agnosia; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Anesthesia and Analgesia; Anesthesia, Conduction; Anesthesia; Ultrasonography; Anesthesia, Local
• Other Study ID Numbers: 111 (Shenzhen Universisty general hospital)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No