Aortic StenosisNCT06911463
Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for TAVI
A study testing suprainguinal fascia iliaca block group (SIFIB), iliohypogastric and ilioinguinal group (IL-IH) and Local infiltration in people with Aortic Stenosis, run by Ain Shams University at 1 site in Egypt.
Trial summary
the aim of the present study is to compare suprainguinal fascia iliaca block and ilioinguinal-iliohypogastric (II-IH) nerve block in improving the quality of conscious sedation, including reducing patients' requirements for analgesia also better satisfaction for both patient and surgeon as regards patient outcome and… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Aortic Stenosis
- What is being tested?
- suprainguinal fascia iliaca block group (SIFIB), iliohypogastric and ilioinguinal group (IL-IH) and Local infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 1 Sep 2025
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged >20 years with severe aortic stenosis undergoing elective, non-emergent, non-urgent transfemoral Sapien 3TM (Edwards Lifesciences Corp., Irvine, CA, USA) or CoreValveTM (Medtronic, Minneapolis, MN, USA) implantation were included in the study
Who cannot join
- younger than 20 years
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for Transcatheter Aortic Valve Implantation (TAVI)
the aim of the present study is to compare suprainguinal fascia iliaca block and ilioinguinal-iliohypogastric (II-IH) nerve block in improving the quality of conscious sedation, including reducing patients' requirements for analgesia also better satisfaction for both patient and surgeon as regards patient outcome and decreasing the incidence of conversion to general anesthesia during TAVI procedure
- Conditions
- Aortic Stenosis
- Being tested
- suprainguinal fascia iliaca block group (SIFIB), iliohypogastric and ilioinguinal group (IL-IH), Local infiltration
- 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.
suprainguinal fascia iliaca block group (SIFIB)Other
The anterior superior iliac spine is identified by a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) the inguinal ligament in the parasagittal plane, following appropriate disinfection and draping of the patient in the supine position. Then, the probe is moved medially, and the internal oblique muscle in the cranial direction, the sartorius muscle in the caudal direction, the bow-tie shape formed by these muscles, the underlying iliacus muscle, and the fascia iliaca surrounding it is visualized. (21) An 80-mm peripheral nerve block needle is inserted from the caudal side, and the iliac fascia is passed. After identification of the correct area following 2 to 3 mL of hydro-dissection, 40 mL of 0.25% bupivacaine is injected.
iliohypogastric and ilioinguinal group (IL-IH)Other
Group II (I): iliohypogastric and ilioinguinal group (IL-IH) After preparation of the inguinal region sterile linear high frequency probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) is placed between the iliac crest and costal margin (more cephalad than the usual location for ilioinguinal block). In this location, the ilioinguinal and iliohypogastric nerves in between the transverses abdominus and internal oblique are well defined (22) After visualization, a 22G 1.5-inch needle is used in out of-plane approach to reach the nerves. After identification of the correct area following 2 to 3 mL of hydro-dissection, 40 mL of 0.25% bupivacaine is injected (kayak sign).
Local infiltrationOther
patients receive infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture.
| Study group | Role | What they receive |
|---|---|---|
| Group I (F) | Active comparator | suprainguinal fascia iliaca block group (SIFIB) Receives: Other: suprainguinal fascia iliaca block group (SIFIB) |
| Group II (I) | Active comparator | iliohypogastric and ilioinguinal group (IL-IH) Receives: Other: iliohypogastric and ilioinguinal group (IL-IH) |
| Group III (C) | Other | control group patients received infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture Receives: Other: Local infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is the timing to the first rescue analgesia
sedation score (RASS), and pain (numerical rating scale [NSR] from 0 [no pain] to 10 [unbearable pain]) at 0 time start of sedation and every 30 min till the end of the procedure then 1, 3, and 6 h after TAVI. While, Pain intensity was assessed using numeric rating scale (NRS 0-10; 0 = no pain; 10 = the worth pains imaginable) in five time-points intraoperatively (femoral artery cannulation (1), aortic valve system introduction (2), aortic valve system removal (3), vessel closure devices insertion (4), the end of the operation (5)). In addition, the need for post TAVI pacing, vascular complications at the TAVI access site during admission, and the length of hospital stay were recorded.
Rescue analgesia will be given When NRS was more than 4, patient discomfort or doctor dis-satisfaction is detected, 0.5 mic /kg fentanyl will be given. The primary outcome is the timing to the first rescue analgesia
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study start1 Mar 2025
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Shabayek, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06911463
- Sponsor's protocol ID
- FMASU R30/2024/2025
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for Transcatheter Aortic Valve Implantation (TAVI)
- ClinicalTrials.gov ID
- NCT06911463
- Acronym / sponsor ID
- FMASU R30/2024/2025
- Conditions
- Aortic Stenosis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 4 Apr 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.
the aim of the present study is to compare suprainguinal fascia iliaca block and ilioinguinal-iliohypogastric (II-IH) nerve block in improving the quality of conscious sedation, including reducing patients' requirements for analgesia also better satisfaction for both patient and surgeon as regards patient outcome and decreasing the incidence of conversion to general anesthesia during TAVI procedure
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I (F) | Active comparator | Other: suprainguinal fascia iliaca block group (SIFIB)suprainguinal fascia iliaca block group (SIFIB) |
| Group II (I) | Active comparator | Other: iliohypogastric and ilioinguinal group (IL-IH)iliohypogastric and ilioinguinal group (IL-IH) |
| Group III (C) | Other | Other: Local infiltrationcontrol group patients received infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- aged >20 years with severe aortic stenosis undergoing elective, non-emergent, non-urgent transfemoral Sapien 3TM (Edwards Lifesciences Corp., Irvine, CA, USA) or CoreValveTM (Medtronic, Minneapolis, MN, USA) implantation were included in the study
Key exclusion criteria (1 listed)
- younger than 20 years
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 |
|---|---|---|
| suprainguinal fascia iliaca block group (SIFIB)The anterior superior iliac spine is identified by a high-frequency linear probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) the inguinal ligament in the parasagittal plane, following appropriate disinfection and draping of the patient in the supine position. Then, the probe is moved medially, and the internal oblique muscle in the cranial direction, the sartorius muscle in the caudal direction, the bow-tie shape formed by these muscles, the underlying iliacus muscle, and the fascia iliaca surrounding it is visualized. (21) An 80-mm peripheral nerve block needle is inserted from the caudal side, and the iliac fascia is passed. After identification of the correct area following 2 to 3 mL of hydro-dissection, 40 mL of 0.25% bupivacaine is injected. | Other | Group I (F) |
| iliohypogastric and ilioinguinal group (IL-IH)Group II (I): iliohypogastric and ilioinguinal group (IL-IH) After preparation of the inguinal region sterile linear high frequency probe (SonoSite HFL50x, 15-6 MHz, 55-mm broadband linear array, USA) is placed between the iliac crest and costal margin (more cephalad than the usual location for ilioinguinal block). In this location, the ilioinguinal and iliohypogastric nerves in between the transverses abdominus and internal oblique are well defined (22) After visualization, a 22G 1.5-inch needle is used in out of-plane approach to reach the nerves. After identification of the correct area following 2 to 3 mL of hydro-dissection, 40 mL of 0.25% bupivacaine is injected (kayak sign). | Other | Group II (I) |
| Local infiltrationpatients receive infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture. | Other | Group III (C) |
Primary outcome
The primary outcome is the timing to the first rescue analgesia
Time frame: Six months
sedation score (RASS), and pain (numerical rating scale [NSR] from 0 [no pain] to 10 [unbearable pain]) at 0 time start of sedation and every 30 min till the end of the procedure then 1, 3, and 6 h after TAVI. While, Pain intensity was assessed using numeric rating scale (NRS 0-10; 0 = no pain; 10 = the worth pains imaginable) in five time-points intraoperatively (femoral artery cannulation (1), aortic valve system introduction (2), aortic valve system removal (3), vessel closure devices insertion (4), the end of the operation (5)). In addition, the need for post TAVI pacing, vascular complications at the TAVI access site during admission, and the length of hospital stay were recorded. Rescue analgesia will be given When NRS was more than 4, patient discomfort or doctor dis-satisfaction is detected, 0.5 mic /kg fentanyl will be given. The primary outcome is the timing to the first rescue analgesia
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 4 Apr 2025.
- Individual participant dataSharing planned: No
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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.
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 suprainguinal fascia iliaca block group (SIFIB), iliohypogastric and ilioinguinal group (IL-IH) and Local infiltration in people with Aortic Stenosis, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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: enrolling by invitation, as of the sponsor's last update on 4 Apr 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 Egypt. 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?
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 primary outcome is the timing to the first rescue analgesia (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Apr 2025.