PENG Block forTranscatheter Aortic Valve Implantation

Not Applicable

Completed

• Conditions: Aortic Valve Stenosis; Aortic Diseases
• Interventions: Drug: Postoperative analgesia management; Drug: Local infiltration-Bupivacaine; Drug: PENG-Bupivacaine

• Registration Number: NCT05904912
• Lead Sponsor: Medipol University

Brief Summary

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.

Detailed 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.).

Study Timeline

• Study First Submitted: 2023-05-26
• Study Start: 2023-06-10
• Study First Submitted QC: 2023-06-14
• Study First Posted: 2023-06-15
• Status Verified: 2023-12
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Last Update Submitted: 2023-12-11
• Last Update Posted: 2023-12-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group C = Control group	Local infiltration-Bupivacaine	Local infiltration will be applied.
Group PENG = PENG block	Postoperative analgesia management	PENG block will be performed
Group C = Control group	Postoperative analgesia management	Local infiltration will be applied.
Group PENG = PENG block	PENG-Bupivacaine	PENG block will be performed

Primary Outcome Measures

Name	Time	Method
Pain scores (Numerical Rating Scale-NRS)	Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

Secondary Outcome Measures

Name	Time	Method
Quadriceps muscle strength	Postoperative 24 hours period	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
The use of rescue analgesia	Postoperative 24 hours period]	Meperidine using

Trial Locations

Locations (1)

Istanbul Medipol University Hospital; 🇹🇷 Istanbul, Bagcilar, Turkey