PENG Block forTranscatheter Aortic Valve Implantation

Medipol University

Status: Completed

Conditions: Aortic Valve Stenosis; Aortic Diseases

Treatments: Drug: Local infiltration-Bupivacaine; Drug: Postoperative analgesia management; Drug: PENG-Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT05904912

Medipol Hospital 32

Details and patient eligibility

About

Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.

Full description

Aortic valve stenosis (AS) is the most common valve pathology, affecting 2% to 4% of patients over the age of 75. Surgical aortic valve replacement (SAVR) has been accepted as a class I recommendation for the treatment of AS for decades. However, given that advanced age, frailty, and significant comorbidities are increasingly common in affected patients; More than one-third of high-risk and severely symptomatic AS patients are physiologically unsuitable for major surgery. This is the development and implementation of TAVI, an appropriate intervention for high-risk patients and those deemed unsuitable for surgery. With a shift in the clinical paradigm towards minimally invasive procedures, the development of TAVI has revolutionized clinical outcomes in AS, particularly in those once considered inoperable.

Selective candidate criteria and advances in operative techniques within TAVI are major contributors to successful outcomes. Basically, there are both retrograde and anterograde operative approaches that can be adopted within a TAVI procedure. While the transfemoral approach remains the most widely used, others include the transapical, transaxillary, transported, and transaortic pathways. The choice of technique adopted is greatly influenced by patient-related factors such as anatomical considerations and comorbidities present.

Because of the increasing use of ultrasound (US) in anesthesia practice, nerve blocks with US guidance are widely used. Pericapsular nerve group (PENG block) is a new fascial block defined by Arango et al. This block aims to block the femoral nerve and the accessory obturator nerve by injecting local anesthetic between the pubic ramus and psoas tendon. By blocking these nerves, anterior hip analgesia is created. It is a safe and effective method as it is applied superficially and under ultrasound guidance. In radiological and cadaver studies, it has been reported that when high volume is applied, total hip analgesia can be achieved by blocking the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves.

This prospective, randomized study, it was aimed to evaluate the efficacy of the PENG block for the management of analgesia during and after the procedure in patients undergoing TAVI. Our primary aim is to evaluate pain scores (Numerical Rating Scale-NRS), our secondary aim is to evaluate the amount of additional sedation intraoperatively, the degree of quadriceps motor block (paresis or paralysis in knee extension), and opioid-related side effects (allergic reaction, nausea, vomiting, etc.).

Enrollment: 40 patients

Sex: All

Ages: 20 to 95 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with ASA classification I-III,
• Aged 20-80 years
• Who will be scheduled for TAVI.

Exclusion criteria

• Patients who have a history of bleeding diathesis,
• Take anticoagulant therapy,
• History of chronic pain before surgery,
• Multiple trauma,
• Who cannot assess their pain (dementia),
• Who have been operated under spinal or epidural anesthesia,
• Who have an infection in the area and do not accept the procedure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Group PENG = PENG block

Active Comparator group

Description:

PENG block will be performed

Treatment:

Drug: PENG-Bupivacaine

Drug: Postoperative analgesia management

Group C = Control group

Other group

Description:

Local infiltration will be applied.

Treatment:

Drug: Local infiltration-Bupivacaine

Drug: Postoperative analgesia management