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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

Patients under 18 years of age,

Patients treated under emergency conditions,

morbid obesity (BMI>35 kg/m2),

pregnant women,

Trial design

Design model

Parallel

Treatments tested in this trial

  • ultrasound

    Device

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

  • parenteral local anesthesia

    Procedure/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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: control groupSham comparator 1 intervention
Group B: block groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
4 months
2

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.

Time frame
4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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