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Enrolling by invitation NCT06911463

Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for TAVI

No phase Interventional Aortic Stenosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: suprainguinal fascia iliaca block group (SIFIB), iliohypogastric and ilioinguinal group (IL-IH), Local infiltration.
Who it may be relevant to
Registry conditions: Aortic Stenosis. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Conscious Sedation With Suprainguinal Facia Iliaca Block Versus Ilioinguinal Iliohypogastric Block for Transcatheter Aortic Valve Implantation (TAVI)

Overview

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

Interventions

  • Other 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
  • Other 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 needl
  • Other Local infiltration
    patients receive infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture.

Primary outcome measures

  • The primary outcome is the timing to the first rescue analgesia [Time frame: Six months]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • younger than 20 years

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Egypt · 1 center
  • Ain Shams university — Cairo

Identifiers

NCT: NCT06911463 · FMASU R30/2024/2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗