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AnesthesiaNCT06762288

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

A study testing Ultrasound and Local anesthesia and sedation in people with Anesthesia and Analgesia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Anesthesia, Analgesia, Block
What is being tested?
Ultrasound and Local anesthesia and sedation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Dec 2024to 2 Feb 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • TAVI procedures
  • over 18 years of age
  • elective procedures
  • Signing the volunteer consent form
  • Providing optimal images in ultrasound imaging

Who cannot join

  • < 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
Show all 9Show fewer
  • Allergic to the prescribed medications
  • Pregnants
  • Those who refused to sign volunteer consent form

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Istanbul University-Cerrahpaşa

    Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Ultrasound, Local anesthesia and sedation
Keywords
transversus abdominis plan block, tavi, transcatheter aortic valve implantation, nerve block, aortic stenosis, interventional cardiology, anesthesia, ultrasound
Medical subject headings
Agnosia, Bites and Stings, Aortic Valve Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasoundDevice

    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.

  • Local anesthesia and sedationProcedure or surgery

    Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.

Study groups in NCT06762288
Study groupRoleWhat they receive
Block groupActive comparatorLocal 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.
Receives: Device: Ultrasound; Procedure: Local anesthesia and sedation
Control groupSham comparatorLocal 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.
Receives: Device: Ultrasound; Procedure: Local anesthesia and sedation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (6)
  1. Total intraprocedural opioid consumption

    Total fentanyl administered(mcg)

    Measured: from induction to end of procedure

  2. 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.

    Measured: from induction to end of procedure

  3. 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)

    Measured: from induction to 60 minutes post-procedure

  4. 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"

    Measured: during procedure

  5. patient satisfaction

    Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)

    Measured: 1 hour after end of procedure

  6. physician satisfaction

    Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)

    Measured: 1 hour after end of procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2025
  2. Study start28 Dec 2024
  3. Primary completion2 Feb 2026
  4. Study completion2 Feb 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06762288
Sponsor's protocol ID
111
Status last verified
Mar 2026
First submitted
1 Jan 2025
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasound and Local anesthesia and sedation in people with Anesthesia and Analgesia, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The pain assessed by the Numeric Rating Scale-11 (NRS-11) to measure the analgesic efficacy of TAP (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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