Aortic Valve StenosisNCT05904912
PENG Block forTranscatheter Aortic Valve Implantation
A study testing Postoperative analgesia management, PENG-Bupivacaine and Local infiltration-Bupivacaine in people with Aortic Valve Stenosis and Aortic Diseases, run by Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 95 years
- Conditions the study is for
- Aortic Valve Stenosis, Aortic Diseases
- What is being tested?
- Postoperative analgesia management, PENG-Bupivacaine and Local infiltration-Bupivacaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jun 2023to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ASA classification I-III,
- Aged 20-80 years
- Who will be scheduled for TAVI.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University Hospital
Istanbul, Bagcilar, 34070
About this study
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
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.
Read the 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.).
- Conditions
- Aortic Valve Stenosis, Aortic Diseases
- Being tested
- Postoperative analgesia management, PENG-Bupivacaine, Local infiltration-Bupivacaine
- Keywords
- Aortic valve stenosis, Transcatheter aortic valv implantation (TAVI), PENG block, Postoperative analgesia management
- Medical subject headings
- Aortic Valve Stenosis, Aortic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative analgesia managementDrug
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-BupivacaineDrug
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-BupivacaineDrug
Local infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team
| Study group | Role | What they receive |
|---|---|---|
| Group PENG = PENG block | Active comparator | PENG block will be performed Receives: Drug: Postoperative analgesia management; Drug: PENG-Bupivacaine |
| Group C = Control group | Other | Local infiltration will be applied. Receives: Drug: Postoperative analgesia management; Drug: Local infiltration-Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
The need for fentanyl during the procedure
Intraoperative additional fentanyl need and dosage will be recorded
Measured: Intraoperative period
Secondary outcomes (3)
Quadriceps muscle strength
Quadriceps muscle strength (knee extension and hip adduction) will be evaluated according to the Oxford muscle strength rating
Measured: Postoperative 24 hours period
The use of rescue analgesia
Meperidine using
Measured: Postoperative 24 hours period]
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)
Measured: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2023
- Study start10 Jun 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Aortic Valve StenosisStudies of the same condition, open and under way.
- More trials run by Medipol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahadir Ciftci, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05904912
- Sponsor's protocol ID
- Medipol Hospital 32
- Status last verified
- Nov 2025
- First submitted
- 26 May 2023
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators will not share IPD
Publications
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.
PubMed 24258463Giron-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.
PubMed 30063657Ahiskalioglu 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.
PubMed 31212123Ciftci 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.
PubMed 34175637Gul YG, Alver S, Ozen V, Golboyu BE, Ciftci B. Pericapsular nerve group block reduces fentanyl use in transcatheter aortic valve implantation: a randomized prospective study. Clin Res Cardiol. 2025 Nov 24. doi: 10.1007/s00392-025-02815-0. Online ahead of print.
PubMed 41284052
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05904912
- Acronym / sponsor ID
- Medipol Hospital 32
- Conditions
- Aortic Valve Stenosis, Aortic Diseases
- Keywords
- Aortic valve stenosis, Transcatheter aortic valv implantation (TAVI), PENG block, Postoperative analgesia management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jun 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 15 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group PENG = PENG block | Active comparator | Drug: Postoperative analgesia management, Drug: PENG-BupivacainePENG block will be performed |
| Group C = Control group | Other | Drug: Postoperative analgesia management, Drug: Local infiltration-BupivacaineLocal infiltration will be applied. |
Who may qualify
- Ages
- 20 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with ASA classification I-III,
- Aged 20-80 years
- Who will be scheduled for TAVI.
Key exclusion criteria (7 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative analgesia managementIntravenous 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 | Group C = Control group, Group PENG = PENG block |
| PENG-BupivacaineThe 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. | Drug | Group PENG = PENG block |
| Local infiltration-BupivacaineLocal infiltration will be applied with 30 ml of a local anesthetic solution containing 0.25% bupivacaine by the surgical team | Drug | Group C = Control group |
Primary outcome
The need for fentanyl during the procedure
Time frame: Intraoperative period
Intraoperative additional fentanyl need and dosage will be recorded
3 secondary outcomes
Quadriceps muscle strength
Time frame: Postoperative 24 hours period
The use of rescue analgesia
Time frame: Postoperative 24 hours period]
Pain scores (Numerical Rating Scale-NRS)
Time frame: Changes from baseline pain scores at postoperative 0, 2, 4, 8, 16 and 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 24258463Clayton 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.
- Background: PubMed 30063657Giron-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.
- Background: PubMed 31212123Ahiskalioglu 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.
- Background: PubMed 34175637Ciftci 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.
- Derived from this study: PubMed 41284052Gul YG, Alver S, Ozen V, Golboyu BE, Ciftci B. Pericapsular nerve group block reduces fentanyl use in transcatheter aortic valve implantation: a randomized prospective study. Clin Res Cardiol. 2025 Nov 24. doi: 10.1007/s00392-025-02815-0. Online ahead of print.
- Individual participant dataSharing planned: No. The investigators will not share IPD
Related trials for Aortic Valve Stenosis
Recruiting
Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR
Aortic Stenosis Treated With TAVI, Aortic Diseases
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Active, not recruitingObservational study
Intravascular Lithotripsy in High Risk Calcified Iliac Anatomy for Transfemoral TAVR
Iliac Disease, Aortic Valve Stenosis
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
Recruiting
Exercise and Diet Supplements for Older Patients Undergoing TAVI: the IRON-TAVI Trial
Aortic Stenosis Disease, Aortic Stenosis Symptomatic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative analgesia management, PENG-Bupivacaine and Local infiltration-Bupivacaine in people with Aortic Valve Stenosis and Aortic Diseases, run by Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The need for fentanyl during the procedure (time frame: Intraoperative period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05904912, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.