PENG Block forTranscatheter Aortic Valve Implantation

Sponsor

Medipol University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05904912

Collaborator

(none)

Enrollment

Location

Arms

3.7

Anticipated Duration (Months)

16.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Aortic Valve Stenosis Aortic Diseases	Drug: Postoperative analgesia management Drug: PENG-Bupivacaine Drug: Local infiltration-Bupivacaine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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:

Double (Participant, Outcomes Assessor)

Masking Description:

Outcomes Assessor and participant will be blinded to the study

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group PENG = PENG block PENG block will be performed	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. Drug: 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.
Other: Group C = Control group Local infiltration will be applied.	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. Drug: Local infiltration-Bupivacaine Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team

Arm

Intervention/Treatment

Active Comparator: Group PENG = PENG block

PENG block will be performed

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.

Drug: 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.

Other: Group C = Control group

Local infiltration will be applied.

Drug: Postoperative analgesia management

Drug: Local infiltration-Bupivacaine

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 95 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Medipol University Hospital	Istanbul	Bagcilar	Turkey	34070

Sponsors and Collaborators

Medipol University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Bahadir Ciftci, Primary researcher, Medipol University

ClinicalTrials.gov Identifier:

NCT05904912

Other Study ID Numbers:

Medipol Hospital 32

First Posted:

Jun 15, 2023

Last Update Posted:

Jun 15, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Bahadir Ciftci, Primary researcher, Medipol University

Aortic valve stenosis

Transcatheter aortic valv implantation (TAVI)

PENG block

Postoperative analgesia management

Additional relevant MeSH terms:

Aortic Valve Stenosis

Aortic Diseases

Bupivacaine

Study Results

No Results Posted as of Jun 15, 2023