Ireland
--:--IST
Recruiting Not applicable

Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Endovascular Cardiac Interventions

NCT06576128 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-09-10
Last updated
2026-05-08

Condition(s) studied

AnesthesiologyPercutaneous Coronary InterventionCardiac CatheterizationAnalgesiaSatisfaction, Patient

Investigational drug(s) / intervention(s)

ultrasoundparenteral local anesthesia

ultrasound: In additional to local anesthesia, 10 ml lidocaine (2%) (Lidon, Onfarma, Turkey ), TAPB will be performed under ultrasound imaging..

parenteral local anesthesia: 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 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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, * 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.

Primary outcome measure(s)

  • measuring the analgesic efficacy of TAPB — 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. — 4 months
    One point represents strongly unsatisfied and 5 points represent strongly satisfied.

Trial sites (1)

FacilityCityRegionStatus
Istanbul University- Cerrahpasa Istanbul Turkey (Türkiye) Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06576128 on ClinicalTrials.gov ↗ ← All trials in Turkey