AnesthesiologyNCT06576128
Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Endovascular Cardiac Interventions
A study testing ultrasound and parenteral local anesthesia in people with Anesthesiology and Percutaneous Coronary Intervention, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
Sensory innervation of the femoral region which is the entry point for endovascular cardiac interventions such as coronary angiography,cardiac catheterization and percutaneous coronary intervention is complex.It is thought that the ilioinguinal and iliohypogastric nerves contribute mostly.With transversus abdominis… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesiology, Percutaneous Coronary Intervention, Cardiac Catheterization
- What is being tested?
- ultrasound and parenteral local anesthesia
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Sep 2024to 15 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- The patient is over 18 years of age
- Coronary angiography, cardiac catheterization and percutaneous coronary intervention will be applied to the patient,
- The above-mentioned procedures will be taken under elective conditions,
- Providing an optimal image when imaging the patient with ultrasound,
- INR< 1.5
- If the patient gives consent, S/he will be included in the study.
Who cannot join
- Patients under 18 years of age,
- Patients treated under emergency conditions,
- morbid obesity (BMI>35 kg/m2),
- pregnant women,
- New York Heart Association (NYHA) stage 4 patients with advanced decompensated heart failure,
- Patients with symptoms such as redness, temperature increase, infection, hematoma in the application area before the procedure,
Show all 10Show fewer
- Patients with a history of allergy to local anesthetics,
- Patients who cannot be communicated,
- Those with severe psychosis or progressive neurological deficits and muscle disease,
- Patients who do not consent to the application will be excluded from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Istanbul University- Cerrahpasa
Istanbul
Gozde Altun, Dr.
About this study
Official title: Analgesic Effect of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Femoral Endovascular Cardiac Interventions: A Prospective-randomized Study
Sensory innervation of the femoral region which is the entry point for endovascular cardiac interventions such as coronary angiography,cardiac catheterization and percutaneous coronary intervention is complex.It is thought that the ilioinguinal and iliohypogastric nerves contribute mostly.With transversus abdominis plane block(TAPB),it is planned to provide analgesia by creating a block in these nerve branches that contribute to the sensory innervation of the intervention area.In addition;it was aimed to investigate patient's and physician's satisfaction during the procedure.
Read the detailed description
Cardiac catheterization was first performed by Werner Frossman in the late 1920s, when the ureteral catheter was advanced in the antecubital vein and demonstrated by fluoroscopy in the right atrium. Over the years, this method was developed; It has been used for more specific and complicated clinical situations.
Coronary angiography was first used for diagnostic purposes in the 1950s. It has continued to exist as a gold standard method in the diagnosis and treatment of coronary artery diseases and some other cardiac pathologies until today.
For endovascular cardiac interventions; femoral, brachial and radial arteries are used. Blood loss and difficulty in achieving hemostasis are harder in femoral artery interventions than other arteries. However, it has been observed that the femoral artery is more frequently preferred in endovascular cardiac interventions. The reason is that the artery has a large lumen (approximately 8-9 mm) and continues after the abdominal aorta and iliac artery. One of the most important reasons for this is that there is very little anatomical variation. The femoral artery can be felt approximately 1/3 medial to the inguinal ligament.After the inguinal ligament, the iliac artery, commonly it is called the femoral artery. Femoral artery is mostly preferred in cardiac interventions. Because this region has common iliac artery it is thought to be safer because it comes before the bifurcation of the femoral artery and after the inferior epigastric artery.
Transversus abdominis plane block (TAPB) aims to block the ilioinguinal and iliohypogastric nerves. In gynecological, urological surgeries, colorectal surgeries, cholecystectomies and inguinal surgeries; it has been used to provide intraoperative and postoperative analgesia.
The transversus abdominis plane is between the internal oblique muscle and the transversus abdominis muscle. In this plane, ilioinguinal and iliohypogastric nerves are located together. Ilioinguinal and iliohypogastric nerves originate from the ventral branches of L1 and in some variations, T12 may also contribute. The sensory innervation of the femoral region where endovascular cardiac interventions are performed is complex. It is thought that the ilioinguinal and iliohypogastric nerves contribute mostly. TAPB aims to provide analgesia by creating a block in these nerve branches that contribute to the sensory innervation of the intervention area.
- Conditions
- Anesthesiology, Percutaneous Coronary Intervention, Cardiac Catheterization, Analgesia, Satisfaction, Patient
- Being tested
- ultrasound, parenteral local anesthesia
- Keywords
- ultrasonography, anesthesiology, transversus abdominis plane block, Percutaneous Coronary Intervention, Cardiac Catheterization, analgesia
- Medical subject headings
- Agnosia, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasoundDevice
In additional to local anesthesia, 10 ml lidocaine (2%) (Lidon, Onfarma, Turkey ), TAPB will be performed under ultrasound imaging..
parenteral local anesthesiaProcedure or surgery
As routine procedure; the cardiologist will palpate the right or left femoral artery under sterile conditions and apply approximately 10 ml lidocaine (2%) to this area as local anesthesia (Lidon, Onfarma, Turkey ). Then, a puncture will be made on the anterior wall of the femoral artery with an 18 G needle . Approximately 3-4 mm skin incision will be made with the number 11 scalpel tip and the Seldinger technique will be continued. 6F femoral sheath to be placed, cardiac The catheterization process will begin.
| Study group | Role | What they receive |
|---|---|---|
| control group | Sham comparator | only local anesthesia will be applied to surgical field as a part of the routine procedure. Receives: Procedure: parenteral local anesthesia |
| block group | Active comparator | local anesthesia will be applied to surgical field as a part of the routine procedure and additionally transversus abdominisl plane block will be applied. Receives: Device: ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
measuring the analgesic efficacy of TAPB
The pain will be assessed by the Numeric Rating Scale-11(NRS -11) to measure the analgesic efficacy of TAPB. Minimum pain score is point zero, maximum pain score is ten points.Minimum pain scores (NRS is less than 4 points) will have positive outcomes.
Measured: 4 months
For patient and physician satisfaction;5-point Likert scale will be used. Minimum satisfaction score is one point, maksimum satisfaction score is five points.Higher scores have positive outcomes.
One point represents strongly unsatisfied and 5 points represent strongly satisfied.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start10 Sep 2024
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiologyStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
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, Study chair, Proffessor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06576128
- Sponsor's protocol ID
- 016
- Status last verified
- May 2025
- First submitted
- 26 Aug 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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 Effect of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Femoral Endovascular Cardiac Interventions: A Prospective-randomized Study
- ClinicalTrials.gov ID
- NCT06576128
- Acronym / sponsor ID
- 016
- Conditions
- Anesthesiology, Percutaneous Coronary Intervention, Cardiac Catheterization, Analgesia, Satisfaction, Patient
- Keywords
- ultrasonography, anesthesiology, transversus abdominis plane block, Percutaneous Coronary Intervention, Cardiac Catheterization, analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 28 Aug 2024 (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.
Sensory innervation of the femoral region which is the entry point for endovascular cardiac interventions such as coronary angiography,cardiac catheterization and percutaneous coronary intervention is complex.It is thought that the ilioinguinal and iliohypogastric nerves contribute mostly.With transversus abdominis plane block(TAPB),it is planned to provide analgesia by creating a block in these nerve branches that contribute to the sensory innervation of the intervention area.In addition;it was aimed to investigate patient's and physician's satisfaction during the procedure.
Detailed description
Cardiac catheterization was first performed by Werner Frossman in the late 1920s, when the ureteral catheter was advanced in the antecubital vein and demonstrated by fluoroscopy in the right atrium. Over the years, this method was developed; It has been used for more specific and complicated clinical situations.
Coronary angiography was first used for diagnostic purposes in the 1950s. It has continued to exist as a gold standard method in the diagnosis and treatment of coronary artery diseases and some other cardiac pathologies until today.
For endovascular cardiac interventions; femoral, brachial and radial arteries are used. Blood loss and difficulty in achieving hemostasis are harder in femoral artery interventions than other arteries. However, it has been observed that the femoral artery is more frequently preferred in endovascular cardiac interventions. The reason is that the artery has a large lumen (approximately 8-9 mm) and continues after the abdominal aorta and iliac artery. One of the most important reasons for this is that there is very little anatomical variation. The femoral artery can be felt approximately 1/3 medial to the inguinal ligament.After the inguinal ligament, the iliac artery, commonly it is called the femoral artery. Femoral artery is mostly preferred in cardiac interventions. Because this region has common iliac artery it is thought to be safer because it comes before the bifurcation of the femoral artery and after the inferior epigastric artery.
Transversus abdominis plane block (TAPB) aims to block the ilioinguinal and iliohypogastric nerves. In gynecological, urological surgeries, colorectal surgeries, cholecystectomies and inguinal surgeries; it has been used to provide intraoperative and postoperative analgesia.
The transversus abdominis plane is between the internal oblique muscle and the transversus abdominis muscle. In this plane, ilioinguinal and iliohypogastric nerves are located together. Ilioinguinal and iliohypogastric nerves originate from the ventral branches of L1 and in some variations, T12 may also contribute. The sensory innervation of the femoral region where endovascular cardiac interventions are performed is complex. It is thought that the ilioinguinal and iliohypogastric nerves contribute mostly. TAPB aims to provide analgesia by creating a block in these nerve branches that contribute to the sensory innervation of the intervention area.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Procedure: parenteral local anesthesiaonly local anesthesia will be applied to surgical field as a part of the routine procedure. |
| block group | Active comparator | Device: ultrasoundlocal anesthesia will be applied to surgical field as a part of the routine procedure and additionally transversus abdominisl plane block will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The patient is over 18 years of age
- Coronary angiography, cardiac catheterization and percutaneous coronary intervention will be applied to the patient,
- The above-mentioned procedures will be taken under elective conditions,
- Providing an optimal image when imaging the patient with ultrasound,
- INR< 1.5
Key exclusion criteria (10 listed)
- Patients under 18 years of age,
- Patients treated under emergency conditions,
- morbid obesity (BMI>35 kg/m2),
- pregnant women,
- New York Heart Association (NYHA) stage 4 patients with advanced decompensated heart failure,
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 |
|---|---|---|
| ultrasoundIn additional to local anesthesia, 10 ml lidocaine (2%) (Lidon, Onfarma, Turkey ), TAPB will be performed under ultrasound imaging.. | Device | block group |
| parenteral local anesthesiaAs routine procedure; the cardiologist will palpate the right or left femoral artery under sterile conditions and apply approximately 10 ml lidocaine (2%) to this area as local anesthesia (Lidon, Onfarma, Turkey ). Then, a puncture will be made on the anterior wall of the femoral artery with an 18 G needle . Approximately 3-4 mm skin incision will be made with the number 11 scalpel tip and the Seldinger technique will be continued. 6F femoral sheath to be placed, cardiac The catheterization process will begin. | Procedure or surgery | control group |
Primary outcome
measuring the analgesic efficacy of TAPB
Time frame: 4 months
The pain will be assessed by the Numeric Rating Scale-11(NRS -11) to measure the analgesic efficacy of TAPB. Minimum pain score is point zero, maximum pain score is ten points.Minimum pain scores (NRS is less than 4 points) will have positive outcomes.
For patient and physician satisfaction;5-point Likert scale will be used. Minimum satisfaction score is one point, maksimum satisfaction score is five points.Higher scores have positive outcomes.
Time frame: 4 months
One point represents strongly unsatisfied and 5 points represent strongly satisfied.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
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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.
Kerem Erkalp study chair
Proffessor
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 parenteral local anesthesia in people with Anesthesiology and Percutaneous Coronary Intervention, 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 6 inclusion and 10 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: looking for participants now, 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gozde Altun (+905544290333, gozde.altun@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measuring the analgesic efficacy of TAPB (time frame: 4 months). The study lists 2 primary outcomes in all. 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; AzTrials last refreshed its copy on 26 Oct 2026.