Transversus Abdominis Plan (TAP) Block In Transcatheter Aortic Valve Implantation (TAVI)

NCT ID: NCT06762288

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-28
• Study Completion Date: 2025-06-30

Brief Summary

Hemodynamic stability is the main goal of the anesthetic method during TAVI. Pain during the procedure may cause patients to move therefore hemodynamic instability. This may lead to undesirable complications for the patient and the physician. At the same time, it may affect the process quality and cause the processing time to be extended. In this prospective-randomised study, ultrasound-guided transversus abdominis plan block will be performed to reduce pain. We aimed to contribute to the reduction of undesirable outcomes for the patient and physician by providing adequate anesthesia with TAP block accompanied by sedation, and to present its impact on the quality of the healthcare service provided by evaluating patient and physician satisfaction.

Detailed Description

While common aortic valve stenosis was previously treated with surgical aortic valve replacement, with the developments in the field of interventional cardiology, TAVI has emerged as an alternative to surgery in recent years and has become the first choice in the treatment of inoperable patients with severe aortic stenosis. Especially patients who are elderly, have chronic illnesses, have a high surgical risk, and whose general health condition is not suitable for surgery can be treated with this method.

Mostly the femoral artery is preferred for TAVİ access because it has a large lumen (8-9 mm) and has less anatomical variation. After the inguinal ligament, the iliac artery, originating from the abdominal aorta, is called the femoral artery. Since this region is safe, it is preferred in cardiac interventions.

Transversus abdominis plane (TAP) block aims to block the ilioinguinal and iliohypogastric nerves which contribute to the sensory innervation of the femoral region used for endovascular cardiac interventions. No studies have been found on the analgesic efficacy of TAP block in TAVİ procedures.

Local anesthesia and sedation as standard procedure will be applied to the control group (C) (n: 25). In TAP block group (TAP) (n:25) standard procedure and unilateral USG-guided TAP block will be performed. In both groups, an additional dose of anesthetic drugs (midazolam 0.05mg/kg and fentanyl 1mcg/kg or propofol 0.5-1mg/kg) will be administered slowly IV when the patient feels pain, wakes up (BIS>80) or moves.

Patients' demographic data, hemodynamic parameters, total anesthetic drug consumption, procedure duration, complications seen during the procedure will be recorded. The highest pain level felt during procedure, when placing and withdrawing sheath and 4 hours after removal will be recorded according to the Numeric rating scale-11 (NRS-11) scoring system. 5-point Likert scale will be used for patient and physician satisfaction.

Cardiac endovascular catheterization procedures such as TAVI are often anxiety-provoking and uncomfortable for patients. The anesthesia method may vary depending on the experience of the cardiology team, the characteristics of the patients and the procedure to be performed. In TAVI procedures, which were initially performed under general anesthesia, a combination of local anesthesia and sedation was preferred as the team's experience developed. Hemodynamic stability and patient immobilization are the main goals of the anesthetic method during TAVI. Due to pain, patients may develop hemodynamic instability and may move. This is an undesirable situation for cardiac patients. It may affect the quality of the procedure for the cardiologist and may cause complications and longer procedure times. Examining the effectiveness of anesthesia by applying TAP block accompanied by sedation and physician and patient satisfaction during and after the procedure forms the basis of the research. First aim of the study is to demonstrate the analgesic effectiveness of ultrasound-guided TAP block application in the femoral region before the procedure in 50 patients who underwent TAVI. Secondary aims are to reduce the need for anesthetic drugs and to investigate patient and physician satisfaction during and after the procedure.

Conditions

Anesthesia; Analgesia; Block; Aortic Valve Stenosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Block group

Local anesthesia and sedation will be applied as standard procedure and unilateral USG-guided TAP block will be performed. In both groups, an additional dose of anesthetic drugs (midazolam 0.05mg/kg and fentanyl 1mcg/kg or propofol 0.5-1mg/kg) will be administered slowly IV when the patient feels pain, wakes up (BIS\>80) or moves.

Group Type: ACTIVE_COMPARATOR

Ultrasound

Intervention Type: DEVICE

Sedation and local anesthesia to the surgical field will be applied as standard procedure and unilateral USG-guided TAP block will be performed to the patients who will undergo TAVİ.

Local anesthesia and sedation

Intervention Type: PROCEDURE

Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.

Control group

Local anesthesia and sedation will be applied as standard procedure in the control group (C) (n: 25). In both groups, an additional dose of anesthetic drugs (midazolam 0.05mg/kg and fentanyl 1mcg/kg or propofol 0.5-1mg/kg or ) will be administered slowly IV when the patient feels pain, wakes up (BIS\>80) or moves

Group Type: SHAM_COMPARATOR

Local anesthesia and sedation

Intervention Type: PROCEDURE

Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.

Interventions

Ultrasound

Sedation and local anesthesia to the surgical field will be applied as standard procedure and unilateral USG-guided TAP block will be performed to the patients who will undergo TAVİ.

Intervention Type: DEVICE

Local anesthesia and sedation

Sedation and local anesthesia to the surgical field will be applied to the patients who will undergo TAVİ.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• TAVI procedures
• over 18 years of age
• INR < 1,5
• elective procedures
• Signing the volunteer consent form
• Providing optimal images in ultrasound imaging

Exclusion Criteria

• < 18 yers of age
• emergency procedures
• morbidly obese patients (BMI>35kg/m2)
• Advanced decompensated heart failure with New york Heart Association (NYHA) stage 4
• Those who have skin infection, lesion, hematoma in the area to be blocked
• Cannot be communicated and cannot be given a position
• Allergic to the prescribed medications
• Pregnants
• Those who refused to sign volunteer consent form

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Kerem Erkalp, MD, Prof

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kerem Erkalp, professor

Role: STUDY_CHAIR

Istanbul University - Cerrahpasa

Locations

Istanbul University-Cerrahpaşa

Istanbul, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Ayla Esin

Role: CONTACT

ayla.esin@iuc.edu.tr

+905326343959

Kerem Erkalp, professor

Role: CONTACT

+905327879500

Facility Contacts

Ayla Esin

Role: primary

aylaesin@hotmail.com

+905326343959

Other Identifiers

111

Identifier Type: -

Identifier Source: org_study_id