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Enrolling by Invitation

NCT Number: NCT06911463

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

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ain Shams university

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 infiltration

Other

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 4, 2025
Registry last updated
Apr 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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