search
Back to results

PENG Block forTranscatheter Aortic Valve Implantation

Primary Purpose

Aortic Valve Stenosis, Aortic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Postoperative analgesia management
PENG-Bupivacaine
Local infiltration-Bupivacaine
Sponsored by
Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Valve Stenosis focused on measuring Aortic valve stenosis, Transcatheter aortic valv implantation (TAVI), PENG block, Postoperative analgesia management

Eligibility Criteria

20 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Istanbul Medipol University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Group PENG = PENG block

Group C = Control group

Arm Description

PENG block will be performed

Local infiltration will be applied.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Quadriceps muscle strength
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
The use of rescue analgesia
Meperidine using

Full Information

First Posted
May 26, 2023
Last Updated
June 14, 2023
Sponsor
Medipol University
search

1. Study Identification

Unique Protocol Identification Number
NCT05904912
Brief Title
PENG Block forTranscatheter Aortic Valve Implantation
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2023 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Valve Stenosis, Aortic Diseases
Keywords
Aortic valve stenosis, Transcatheter aortic valv implantation (TAVI), PENG block, Postoperative analgesia management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
Outcomes Assessor and participant will be blinded to the study
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group PENG = PENG block
Arm Type
Active Comparator
Arm Description
PENG block will be performed
Arm Title
Group C = Control group
Arm Type
Other
Arm Description
Local infiltration will be applied.
Intervention Type
Drug
Intervention Name(s)
Postoperative analgesia management
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PENG-Bupivacaine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Local infiltration-Bupivacaine
Intervention Description
Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team
Primary Outcome Measure Information:
Title
Pain scores (Numerical Rating Scale-NRS)
Description
Postoperative pain assessment will be performed using the NRS score (0 = no pain, 10 = the most severe pain felt)
Time Frame
Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Secondary Outcome Measure Information:
Title
Quadriceps muscle strength
Description
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
Time Frame
Postoperative 24 hours period
Title
The use of rescue analgesia
Description
Meperidine using
Time Frame
Postoperative 24 hours period]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bahadır Çiftçi, Assoc prof, MD
Phone
05343736865
Email
bciftci@medipol.edu.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Selçuk Alver, Assist prof, MD
Email
selcukalver@yahoo.com
Facility Information:
Facility Name
Istanbul Medipol University Hospital
City
Istanbul
State/Province
Bagcilar
ZIP/Postal Code
34070
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bahadir Ciftci, MD
Phone
+905325034428
Email
bciftci@medipol.edu.tr

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The investigators will not share IPD
Citations:
PubMed Identifier
24258463
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.
Results Reference
background
PubMed Identifier
30063657
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.
Results Reference
background
PubMed Identifier
31212123
Citation
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.
Results Reference
background
PubMed Identifier
34175637
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.
Results Reference
background

Learn more about this trial

PENG Block forTranscatheter Aortic Valve Implantation

We'll reach out to this number within 24 hrs