PENG Block forTranscatheter Aortic Valve Implantation

Aortic Valve Stenosis Clinical Trial

Official title:

Evaluation of the Effect of Ultrasound-guided PENG Block on Postoperative Analgesia Management in Patients Undergoing Transcatheter Aortic Valve Implantation: A Randomized, Prospective Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05904912
• Other study ID #: Medipol Hospital 32
• Status: Completed
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: December 7, 2023

Study information

• Verified date: December 2023
• Source: Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 7, 2023
• Est. primary completion date: December 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Valve Stenosis

Intervention

Drug:
• Postoperative analgesia management
Intravenous 0.5 mg/kg tramodol and 1 gr paracetamol will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered iparacetamol iv 1 gr 3x1. Postoperative patient evaluation will be performed by another pain nurse who is unaware of the procedure. If the NRS score is = 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
• PENG-Bupivacaine
The probe will be placed on the anterior inferior iliac crest in the transverse plane. Then, the pubic ramus will be visualized by rotating 45 degrees. The femoral artery, iliopubic process, and psoas muscle will be visualized. The needle will be punctured with the in-plane method to reach between the pubic ramus and the psoas tendon. After the block area is confirmed with 5 ml of saline, 30 ml of local anesthetic solution containing 0.25% bupivacaine will be injected.
• Local infiltration-Bupivacaine
Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University Hospital	Istanbul	Bagcilar

Sponsors (1)

Lead Sponsor	Collaborator
Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Ahiskalioglu A, Aydin ME, Ahiskalioglu EO, Tuncer K, Celik M. Pericapsular nerve group (PENG) block for surgical anesthesia of medial thigh. J Clin Anesth. 2020 Feb;59:42-43. doi: 10.1016/j.jclinane.2019.06.021. Epub 2019 Jun 15. No abstract available. — View Citation

Ciftci B, Ahiskalioglu A, Altintas HM, Tekin B, Sakul BU, Alici HA. A possible mechanism of motor blockade of high volume pericapsular nerve group (PENG) block: A cadaveric study. J Clin Anesth. 2021 Nov;74:110407. doi: 10.1016/j.jclinane.2021.110407. Epub 2021 Jun 24. No abstract available. — View Citation

Clayton B, Morgan-Hughes G, Roobottom C. Transcatheter aortic valve insertion (TAVI): a review. Br J Radiol. 2014 Jan;87(1033):20130595. doi: 10.1259/bjr.20130595. Epub 2013 Nov 20. — View Citation

Giron-Arango L, Peng PWH, Chin KJ, Brull R, Perlas A. Pericapsular Nerve Group (PENG) Block for Hip Fracture. Reg Anesth Pain Med. 2018 Nov;43(8):859-863. doi: 10.1097/AAP.0000000000000847. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores (Numerical Rating Scale-NRS)	Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)	Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Secondary	Quadriceps muscle strength	Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating	Postoperative 24 hours period
Secondary	The use of rescue analgesia	Meperidine using	Postoperative 24 hours period]