Clinical trial NCT06576128: Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Endovascular Cardiac Interventions
Official title: Analgesic Effect of Ultrasound-Guided Transversus Abdominis Plan (TAP) Block in Femoral Endovascular Cardiac Interventions: A Prospective-randomized Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anesthesiology
Percutaneous Coronary Intervention
Cardiac Catheterization
Analgesia
Satisfaction, Patient
Keywords: ultrasonography
anesthesiology
transversus abdominis plane block
Percutaneous Coronary Intervention
Cardiac Catheterization
analgesia
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: measuring the analgesic efficacy of TAPB
timeFrame: 4 months
measure: 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.
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University- Cerrahpasa
Study officials:
affiliation: Proffessor
name: Kerem Erkalp
role: STUDY_CHAIR
References: