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

NCT06762288 | Completed

• 1 other identifier: 111
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 three-blinded prospective-randomised clinical trial, 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.

Conditions

Anesthesia; Analgesia; Block; Aortic Valve Stenosis

Keywords

transversus abdominis plan block; tavi; transcatheter aortic valve implantation; nerve block; aortic stenosis; interventional cardiology; anesthesia; ultrasound

Outcome Measures

Primary Outcomes (1)

• The pain assessed by the Numeric Rating Scale-11 (NRS-11) to measure the analgesic efficacy of TAP

  The Numeric Pain Rating Scale (NPRS) is perhaps the most frequently applied scale used to quantify pain intensity in the clinical setting. It is an 11-point numeric scale, ranging from 0 indicating no pain to 10 indicating worst pain imaginable

  6 months

Secondary Outcomes (2)

• Investigation patient and physician satisfaction assessed by 5-point Likert scale

  6 months

• Evaluate the need for anesthetic drugs

  6 months

Study Arms (2)

Block group

ACTIVE COMPARATOR

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.

Device: Ultrasound; Procedure: Local anesthesia and sedation

Control group

SHAM COMPARATOR

Local anesthesia and sedation will be administered according to standard procedure. In the control group a simulated TAP block procedure was performed under identical sterile and ultrasound-guided conditions without injection of any solution. The needle was advanced to simulate the TAP block technique and maintain blinding; however, no local anesthetic was administered (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

Device: Ultrasound; Procedure: Local anesthesia and sedation

Interventions

Ultrasound 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.

Block group; Control group

Local anesthesia and sedation PROCEDURE

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

Block group; Control group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Bites and Stings; Aortic Valve Stenosis

Interventions

Ultrasonography; Anesthesia, Local

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries; Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Kerem Erkalp, professor

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and outcome assessors will be blinded to group allocation. Randomization codes will be generated by an independent statistician and concealed using sealed opaque envelopes. Study interventions will be prepared by an independent anesthesiologist not involved in intraoperative or postoperative management and assessments. Data analysis will be conducted using coded group labels, and the statistician will remain blinded until completion of the final analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: January 1, 2025
• First Posted: January 7, 2025
• Study Start: December 28, 2024
• Primary Completion: February 2, 2026
• Study Completion: February 2, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)