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

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.

Study Overview

• Status: Recruiting
• Conditions: Analgesia; Satisfaction, Patient; Percutaneous Coronary Intervention; Cardiac Catheterization; Anesthesiology
• Intervention / Treatment: Procedure: parenteral local anesthesia; Device: ultrasound

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: GOZDE ALTUN; Phone Number: +905544290333; Email: gozde.altun@iuc.edu.tr
• Study Contact Backup: Name: Kerem Erkalp; Phone Number: +905327879500; Email: keremerkalp@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Istanbul University- Cerrahpasa
    • Contact: Gozde Altun, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: control group; only local anesthesia will be applied to surgical field as a part of the routine procedure.	Procedure: 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.
Active Comparator: block group; local anesthesia will be applied to surgical field as a part of the routine procedure and additionally transversus abdominisl plane block will be applied.	Device: ultrasound; In additional to local anesthesia, 10 ml lidocaine (2%) (Lidon, Onfarma, Turkey ), TAPB will be performed under ultrasound imaging..

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	4 months

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa
• Investigators: Study Chair: Kerem Erkalp, Proffessor

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2024
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): December 15, 2026

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Percutaneous Coronary Intervention; analgesia; transversus abdominis plane block; ultrasonography; Cardiac Catheterization; anesthesiology
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Agnosia; Patient Satisfaction; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Imaging; Ultrasonography
• Other Study ID Numbers: 016 (Nahrain Medical Research Collective (NMRC))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No