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Clinical Trials/NCT05904912
NCT05904912
Completed
Not Applicable

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

Medipol University1 site in 1 country40 target enrollmentJune 10, 2023

Overview

Phase
Not Applicable
Intervention
Postoperative analgesia management
Conditions
Aortic Valve Stenosis
Sponsor
Medipol University
Enrollment
40
Locations
1
Primary Endpoint
The need for fentanyl during the procedure
Status
Completed
Last Updated
5 months ago

Overview

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.).

Registry
clinicaltrials.gov
Start Date
June 10, 2023
End Date
December 7, 2023
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Medipol University
Responsible Party
Principal Investigator
Principal Investigator

Bahadir Ciftci

Primary researcher

Medipol University

Eligibility Criteria

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

Arms & Interventions

Group PENG = PENG block

PENG block will be performed

Intervention: Postoperative analgesia management

Group PENG = PENG block

PENG block will be performed

Intervention: PENG-Bupivacaine

Group C = Control group

Local infiltration will be applied.

Intervention: Postoperative analgesia management

Group C = Control group

Local infiltration will be applied.

Intervention: Local infiltration-Bupivacaine

Outcomes

Primary Outcomes

The need for fentanyl during the procedure

Time Frame: Intraoperative period

Intraoperative additional fentanyl need and dosage will be recorded

Secondary Outcomes

  • Quadriceps muscle strength(Postoperative 24 hours period)
  • The use of rescue analgesia(Postoperative 24 hours period])
  • Pain scores (Numerical Rating Scale-NRS)(Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours)

Study Sites (1)

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