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

NCT06576128 | Recruiting

• 1 other identifier: 016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesiology; Percutaneous Coronary Intervention; Cardiac Catheterization; Analgesia; Satisfaction, Patient

Keywords

ultrasonography; anesthesiology; transversus abdominis plane block; Percutaneous Coronary Intervention; Cardiac Catheterization; analgesia

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

control group

SHAM COMPARATOR

only local anesthesia will be applied to surgical field as a part of the routine procedure.

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.

Device: ultrasound

Interventions

ultrasound DEVICE

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

block group

parenteral local anesthesia PROCEDURE

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.

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University- Cerrahpasa

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Agnosia; Patient Satisfaction

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Kerem Erkalp

  Proffessor

  STUDY CHAIR

Central Study Contacts

Gozde Altun

CONTACT

+905544290333; gozde.altun@iuc.edu.tr

Kerem Erkalp

CONTACT

+905327879500; keremerkalp@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: proffessor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: September 10, 2024
• Primary Completion: October 15, 2025
• Study Completion: December 15, 2025
• Last Updated: September 10, 2025

Record last verified: 2025-05

Locations

TU (1)