Aortic Valve StenosisNCT06773780
Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management
A study testing local infiltration, PENG and FİB in people with Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, run by Medipol University at 1 site in Turkey (Türkiye).
Trial summary
Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Pericapsular Nerve Group Block
- What is being tested?
- local infiltration, PENG and FİB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2025to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for TAVİ
- aged between 18 and 85 years,
- American Society of Anesthesiology (ASA) physical status II-IV
Who cannot join
- History of bleeding diathesis.
- Use of anticoagulant therapy.
- History of chronic pain prior to surgery.
- Multiple trauma.
- Conditions where pain assessment cannot be performed (e.g., dementia).
- Patients operated under spinal or epidural anesthesia.
- Presence of infection in the region where the block will be applied.
- Refusal to consent to the procedure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Medipol University
Istanbul
Burak Ömür, +905056215056, burakomur@outlook.com
About this study
Official title: Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management - A Randomized, Prospective Study
Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures.
Patient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available.
Read more
The Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves.
This study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.
Read the detailed description
Aortic Stenosis (AS) is the most common valvular pathology, affecting 2% to 4% of individuals over the age of 75. Surgical Aortic Valve Replacement (SAVR) has long been considered the first-line recommendation for AS treatment. However, due to advanced age and the increasing prevalence of severe comorbidities, more than one-third of high-risk and severely symptomatic AS patients are deemed physiologically unsuitable for major surgical interventions.
This situation has led to the development and implementation of Transcatheter Aortic Valve Implantation (TAVI) as an alternative intervention for high-risk patients and those deemed unsuitable for surgery. This shift towards minimally invasive procedures has resulted in revolutionary improvements in clinical outcomes, particularly for AS patients previously considered ineligible for surgery.
Advances in patient selection criteria and operative techniques have made significant contributions to the success of TAVI. Both retrograde and anterograde operative approaches can be employed during the TAVI procedure. While the transfemoral approach remains the most commonly used technique, alternative methods such as transapical, transaxillary, transcarotid, and transaortic approaches are also available. The choice of operative technique largely depends on patient-specific anatomical features and existing comorbidities.
Pericapsular Nerve Group Block (PENG Block) The increasing use of ultrasound (US) in anesthetic practice has facilitated the frequent application of US-guided nerve blocks. The Pericapsular Nerve Group Block (PENG Block) is a novel fascial block first described by Arango et al. In this technique, local anesthetic is injected between the pubic ramus and the psoas tendon, targeting the femoral and accessory obturator nerves to provide effective analgesia for the anterior hip region.
The PENG block has the advantage of not causing motor block. Its superficial applicability makes it a safe and effective method. Radiological and cadaver studies have shown that high-volume local anesthetic injections can also block the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves, enabling total hip analgesia.
Fascia Iliaca Block (FIB) The Fascia Iliaca Block (FIB) is an effective fascial block technique capable of simultaneously affecting multiple nerves. This block aims to anesthetize the lateral femoral cutaneous, obturator, and femoral nerves, providing broad analgesic coverage. FIB is performed away from critical inguinal neurovascular structures, enhancing its reliability. It is particularly preferred in pain management scenarios, such as acute hip fractures, and is considered a safe option for these clinical situations.
Aim of the Study This prospective, randomized study aims to compare the sedation requirements during the procedure and the postoperative analgesia management in TAVI patients undergoing PENG block, FIB, or local infiltration anesthesia. The primary objective is to evaluate the sedation needs of patients during the procedure. The secondary objectives include comparing postoperative pain scores (Numerical Rating Scale - NRS), the presence of quadriceps motor block (paretic or paralytic knee extension), opioid consumption, and opioid-related side effects (e.g., allergic reactions, nausea, vomiting).
This study aims to analyze the efficacy and safety of different analgesia methods, contributing to the identification of optimal strategies to enhance patient comfort and safety during TAVI procedures.
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Pericapsular Nerve Group Block, Fascia Iliaca Block
- Being tested
- local infiltration, PENG, FİB
- Medical subject headings
- Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
local infiltrationDrug
The block procedure will be performed before the surgical procedure, following the induction of sedoanalgesia. Under sterile conditions, 30 mL of 0.25% bupivacaine will be administered to the targeted infiltration area. The local anesthetic will be specifically applied around the arterial and venous puncture sites.
PENGDrug
With the patient in the supine position, a convex ultrasound (US) probe (4-8 MHz, Vivid Q) will be covered with a sterile sheath. An 80-mm block needle (Braun 360°) will be used. The probe will be placed transversely over the anterior inferior iliac spine. Subsequently, the probe will be rotated 45 degrees to visualize the pubic ramus. Once the femoral artery, iliopubic eminence, and psoas muscle are identified under ultrasound guidance, the needle will be advanced using an in-plane technique and positioned between the pubic ramus and the psoas tendon. After confirming the block site with 5 mL of saline, 30 mL of 0.25% bupivacaine will be injected as the local anesthetic.
FİBDrug
The patient's legs will be positioned slightly externally rotated. A high-frequency ultrasound probe will be placed transversely along the inguinal ligament. Under ultrasound guidance, the femoral artery, iliopsoas muscle, and fascia iliaca will be identified. The needle will be advanced parallel to the ultrasound probe using the in-plane technique and positioned beneath the fascia iliaca. After confirming negative aspiration, 30 mL of 0.25% bupivacaine will be injected, and the spread of the solution beneath the fascia iliaca will be verified using ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Local infiltration | Active comparator | Under sterile conditions, 30 ml of 0.25% bupivacaine will be applied to the targeted infiltration area. Receives: Drug: local infiltration |
| PENG | Active comparator | For the PENG block, the patient is placed in the supine position, and a sterile-covered convex ultrasound probe is positioned transversely over the anterior inferior iliac spine. After identifying the femoral artery, iliopubic eminence, and psoas muscle, the needle is advanced in-plane between the pubic ramus and psoas tendon, and 30 mL of 0.25% bupivacaine is injected. Receives: Drug: PENG |
| FİB | Active comparator | For the FIB, with the patient's legs slightly externally rotated, a high-frequency ultrasound probe is placed along the inguinal ligament. The needle is advanced beneath the fascia iliaca, and 30 mL of 0.25% bupivacaine is injected under ultrasound guidance. Receives: Drug: FİB |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated.
The amounts of anesthetic and opioid drugs used during the procedure will be compared.
Measured: during the procedure
Secondary outcomes (2)
the aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.
The NRS is an 11-point scale. Zero means 'no pain', 10 means 'the most severe pain imaginable'. NRS scores at rest and during mobilization are evaluated and recorded in the postoperative recovery unit at 3, 6, 12, 18 and 24 hours. If the NRS score is ≥ 4, 1 mg kg-1 IV tramadol is administered as a rescue analgesic.
Measured: first 24 hours after the operation
The aim of this study is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression) of the patients between the groups.
It will be evaluated whether there are any opioid-related side effects.
Measured: first 24 hours after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start10 Jan 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Omur, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773780
- Sponsor's protocol ID
- TAVİ PENG VS FİB
- Status last verified
- Jul 2026
- First submitted
- 27 Dec 2024
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
PubMed 16980116Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
PubMed 20961243Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
PubMed 21639811Giron-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 30063657Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
PubMed 21401544
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcatheter Aortic Valve Implantation: Comparison of the Effects of Ultrasound-Guided Pericapsular Nerve Group Block and Fascia Iliaca Block on Postoperative Analgesia Management - A Randomized, Prospective Study
- ClinicalTrials.gov ID
- NCT06773780
- Acronym / sponsor ID
- TAVİ PENG VS FİB
- Conditions
- Aortic Valve Stenosis, Transcatheter Aortic Valve Implantation, Pericapsular Nerve Group Block, Fascia Iliaca Block
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipol UniversityUniversity, hospital or other
- Study start
- 10 Jan 2025 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 14 Jan 2025 (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.
Aortic Stenosis (AS) is the most common valvular pathology, particularly prevalent in advanced age, and Transcatheter Aortic Valve Implantation (TAVI) has become a crucial treatment option for high-risk patients who are not suitable for surgery. This minimally invasive approach has demonstrated successful clinical outcomes in patients deemed ineligible for surgical procedures.
Patient selection criteria and advancements in operative techniques are critical for achieving successful TAVI outcomes. While the transfemoral approach is the most commonly used method, alternative techniques such as transapical, transaxillary, transcarotid, and transaortic approaches are also available.
The Pericapsular Nerve Group Block (PENG) targets the femoral and accessory obturator nerves, providing analgesia to the anterior hip without causing motor block. The Fascia Iliaca Block (FIB), on the other hand, provides broader analgesic coverage by affecting the lateral femoral cutaneous, obturator, and femoral nerves.
This study aims to compare PENG block, FIB, and local infiltration anesthesia in TAVI patients regarding sedation requirements during the procedure and postoperative analgesia management. Additionally, pain scores, motor block presence, opioid consumption, and side effects will be assessed. The study seeks to identify optimal strategies to enhance patient comfort and safety during TAVI procedures.
Detailed description
Aortic Stenosis (AS) is the most common valvular pathology, affecting 2% to 4% of individuals over the age of 75. Surgical Aortic Valve Replacement (SAVR) has long been considered the first-line recommendation for AS treatment. However, due to advanced age and the increasing prevalence of severe comorbidities, more than one-third of high-risk and severely symptomatic AS patients are deemed physiologically unsuitable for major surgical interventions.
This situation has led to the development and implementation of Transcatheter Aortic Valve Implantation (TAVI) as an alternative intervention for high-risk patients and those deemed unsuitable for surgery. This shift towards minimally invasive procedures has resulted in revolutionary improvements in clinical outcomes, particularly for AS patients previously considered ineligible for surgery.
Advances in patient selection criteria and operative techniques have made significant contributions to the success of TAVI. Both retrograde and anterograde operative approaches can be employed during the TAVI procedure. While the transfemoral approach remains the most commonly used technique, alternative methods such as transapical, transaxillary, transcarotid, and transaortic approaches are also available. The choice of operative technique largely depends on patient-specific anatomical features and existing comorbidities.
Pericapsular Nerve Group Block (PENG Block) The increasing use of ultrasound (US) in anesthetic practice has facilitated the frequent application of US-guided nerve blocks. The Pericapsular Nerve Group Block (PENG Block) is a novel fascial block first described by Arango et al. In this technique, local anesthetic is injected between the pubic ramus and the psoas tendon, targeting the femoral and accessory obturator nerves to provide effective analgesia for the anterior hip region.
The PENG block has the advantage of not causing motor block. Its superficial applicability makes it a safe and effective method. Radiological and cadaver studies have shown that high-volume local anesthetic injections can also block the lateral femoral cutaneous, genitofemoral, obturator, and femoral nerves, enabling total hip analgesia.
Fascia Iliaca Block (FIB) The Fascia Iliaca Block (FIB) is an effective fascial block technique capable of simultaneously affecting multiple nerves. This block aims to anesthetize the lateral femoral cutaneous, obturator, and femoral nerves, providing broad analgesic coverage. FIB is performed away from critical inguinal neurovascular structures, enhancing its reliability. It is particularly preferred in pain management scenarios, such as acute hip fractures, and is considered a safe option for these clinical situations.
Aim of the Study This prospective, randomized study aims to compare the sedation requirements during the procedure and the postoperative analgesia management in TAVI patients undergoing PENG block, FIB, or local infiltration anesthesia. The primary objective is to evaluate the sedation needs of patients during the procedure. The secondary objectives include comparing postoperative pain scores (Numerical Rating Scale - NRS), the presence of quadriceps motor block (paretic or paralytic knee extension), opioid consumption, and opioid-related side effects (e.g., allergic reactions, nausea, vomiting).
This study aims to analyze the efficacy and safety of different analgesia methods, contributing to the identification of optimal strategies to enhance patient comfort and safety during TAVI procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Local infiltration | Active comparator | Drug: local infiltrationUnder sterile conditions, 30 ml of 0.25% bupivacaine will be applied to the targeted infiltration area. |
| PENG | Active comparator | Drug: PENGFor the PENG block, the patient is placed in the supine position, and a sterile-covered convex ultrasound probe is positioned transversely over the anterior inferior iliac spine. After identifying the femoral artery, iliopubic eminence, and psoas muscle, the needle is advanced in-plane between the pubic ramus and psoas tendon, and 30 mL of 0.25% bupivacaine is injected. |
| FİB | Active comparator | Drug: FİBFor the FIB, with the patient's legs slightly externally rotated, a high-frequency ultrasound probe is placed along the inguinal ligament. The needle is advanced beneath the fascia iliaca, and 30 mL of 0.25% bupivacaine is injected under ultrasound guidance. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients scheduled for TAVİ
- aged between 18 and 85 years,
- American Society of Anesthesiology (ASA) physical status II-IV
Key exclusion criteria (8 listed)
- History of bleeding diathesis.
- Use of anticoagulant therapy.
- History of chronic pain prior to surgery.
- Multiple trauma.
- Conditions where pain assessment cannot be performed (e.g., 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 |
|---|---|---|
| local infiltrationThe block procedure will be performed before the surgical procedure, following the induction of sedoanalgesia. Under sterile conditions, 30 mL of 0.25% bupivacaine will be administered to the targeted infiltration area. The local anesthetic will be specifically applied around the arterial and venous puncture sites. | Drug | Local infiltration |
| PENGWith the patient in the supine position, a convex ultrasound (US) probe (4-8 MHz, Vivid Q) will be covered with a sterile sheath. An 80-mm block needle (Braun 360°) will be used. The probe will be placed transversely over the anterior inferior iliac spine. Subsequently, the probe will be rotated 45 degrees to visualize the pubic ramus. Once the femoral artery, iliopubic eminence, and psoas muscle are identified under ultrasound guidance, the needle will be advanced using an in-plane technique and positioned between the pubic ramus and the psoas tendon. After confirming the block site with 5 mL of saline, 30 mL of 0.25% bupivacaine will be injected as the local anesthetic. | Drug | PENG |
| FİBThe patient's legs will be positioned slightly externally rotated. A high-frequency ultrasound probe will be placed transversely along the inguinal ligament. Under ultrasound guidance, the femoral artery, iliopsoas muscle, and fascia iliaca will be identified. The needle will be advanced parallel to the ultrasound probe using the in-plane technique and positioned beneath the fascia iliaca. After confirming negative aspiration, 30 mL of 0.25% bupivacaine will be injected, and the spread of the solution beneath the fascia iliaca will be verified using ultrasound. | Drug | FİB |
Primary outcome
The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated.
Time frame: during the procedure
The amounts of anesthetic and opioid drugs used during the procedure will be compared.
2 secondary outcomes
the aim of this study is to compare postoperative NRS (Numerical Rating Scale) pain scores of the patients between the groups.
Time frame: first 24 hours after the operation
The aim of this study is to compare opioid-related side effects (such as nausea, vomiting, respiratory depression) of the patients between the groups.
Time frame: first 24 hours after the operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 16980116Nkomo VT, Gardin JM, Skelton TN, Gottdiener JS, Scott CG, Enriquez-Sarano M. Burden of valvular heart diseases: a population-based study. Lancet. 2006 Sep 16;368(9540):1005-11. doi: 10.1016/S0140-6736(06)69208-8.
- Background: PubMed 20961243Leon MB, Smith CR, Mack M, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Brown DL, Block PC, Guyton RA, Pichard AD, Bavaria JE, Herrmann HC, Douglas PS, Petersen JL, Akin JJ, Anderson WN, Wang D, Pocock S; PARTNER Trial Investigators. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010 Oct 21;363(17):1597-607. doi: 10.1056/NEJMoa1008232. Epub 2010 Sep 22.
- Background: PubMed 21639811Smith CR, Leon MB, Mack MJ, Miller DC, Moses JW, Svensson LG, Tuzcu EM, Webb JG, Fontana GP, Makkar RR, Williams M, Dewey T, Kapadia S, Babaliaros V, Thourani VH, Corso P, Pichard AD, Bavaria JE, Herrmann HC, Akin JJ, Anderson WN, Wang D, Pocock SJ; PARTNER Trial Investigators. Transcatheter versus surgical aortic-valve replacement in high-risk patients. N Engl J Med. 2011 Jun 9;364(23):2187-98. doi: 10.1056/NEJMoa1103510. Epub 2011 Jun 5.
- 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 21401544Hebbard P, Ivanusic J, Sha S. Ultrasound-guided supra-inguinal fascia iliaca block: a cadaveric evaluation of a novel approach. Anaesthesia. 2011 Apr;66(4):300-5. doi: 10.1111/j.1365-2044.2011.06628.x. Epub 2011 Feb 24.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing local infiltration, PENG and FİB in people with Aortic Valve Stenosis and Transcatheter Aortic Valve Implantation, 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 8 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: looking for participants now, as of the sponsor's last update on 27 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Burak Ömür (+905056215056, bomur@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency of sedation requirements and the amount of sedative medication used during the TAVI procedure will be evaluated. (time frame: during the procedure). 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 NCT06773780, 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 27 Jul 2026.