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).
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
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- 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
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- Allergic to the prescribed medications
- Pregnants
- Those who refused to sign volunteer consent form
Trial locations and contacts
1 site in 1 country.
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.
- Conditions
- Anesthesia, Analgesia, Block, Aortic Valve Stenosis
- 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 group | Role | What they receive |
|---|---|---|
| Block group | Active comparator | 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. Receives: Device: Ultrasound; Procedure: Local anesthesia and sedation |
| Control group | Sham comparator | 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. 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.
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)
Total intraprocedural opioid consumption
Total fentanyl administered(mcg)
Measured: 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.
Measured: 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)
Measured: 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"
Measured: during procedure
patient satisfaction
Five-point Likert scale (1-5) (1=very dissatisfied, 5= very satisfied)
Measured: 1 hour after end of procedure
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.
- First posted7 Jan 2025
- Study start28 Dec 2024
- Primary completion2 Feb 2026
- Study completion2 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerem Erkalp, MD, Prof, Istanbul University - Cerrahpasa
- Investigators
- Kerem Erkalp, professor, Study chair, Istanbul University - Cerrahpasa
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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effectiveness Of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block In Transfemoral Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT06762288
- Acronym / sponsor ID
- 111
- Conditions
- Anesthesia, Analgesia, Block, Aortic Valve Stenosis
- Keywords
- transversus abdominis plan block, tavi, transcatheter aortic valve implantation, nerve block, aortic stenosis, interventional cardiology, anesthesia, ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 28 Dec 2024 (actual)
- Primary completion
- 2 Feb 2026 (actual)
- Study completion
- 2 Feb 2026 (actual)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Block group | Active comparator | Device: Ultrasound, Procedure: Local anesthesia and sedationLocal 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. |
| Control group | Sham comparator | Device: Ultrasound, Procedure: Local anesthesia and sedationLocal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- TAVI procedures
- over 18 years of age
- elective procedures
- Signing the volunteer consent form
- Providing optimal images in ultrasound imaging
Key exclusion criteria (9 listed)
- < 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundSedation 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. | Device | Block group, Control group |
| Local anesthesia and sedationSedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ. | Procedure or surgery | Block group, Control group |
Primary outcome
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.
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.
6 secondary outcomes
Total intraprocedural opioid consumption
Time frame: from induction to end of procedure
Incidence of rescue sedo-analgesia requirement
Time frame: from induction to end of procedure
incidence of sedation-related complications
Time frame: from induction to 60 minutes post-procedure
unexpected patient movement
Time frame: during procedure
patient satisfaction
Time frame: 1 hour after end of procedure
physician satisfaction
Time frame: 1 hour after end of procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kerem Erkalp, professor study chair
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
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.