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PENG Block forTranscatheter Aortic Valve Implantation

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05904912
Enrollment
40
Registered
2023-06-15
Start date
2023-06-10
Completion date
2023-12-07
Last updated
2025-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Aortic Diseases

Keywords

Aortic valve stenosis, Transcatheter aortic valv implantation (TAVI), PENG block, Postoperative analgesia management

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.).

Interventions

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.

DRUGPENG-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.

DRUGLocal infiltration-Bupivacaine

Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team

Sponsors

Medipol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Outcomes Assessor and participant will be blinded to the study

Intervention model description

Sixty patients aged 20-95 years old with American Society of Anesthesiologists (ASA) classification I-IV and scheduled for TAVI will be included in the study. Patients will be randomly divided into two groups (Group PENG = PENG block group, Group Control = local infiltration group) including 30 patients each, before entering the operating room.

Eligibility

Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
The need for fentanyl during the procedureIntraoperative periodIntraoperative additional fentanyl need and dosage will be recorded

Secondary

MeasureTime frameDescription
Quadriceps muscle strengthPostoperative 24 hours periodQuadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
The use of rescue analgesiaPostoperative 24 hours period]Meperidine using
Pain scores (Numerical Rating Scale-NRS)Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hoursPostoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026