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

NCT06911463 | Enrolling By Invitation

• 1 other identifier: FMASU R30/2024/2025
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 decreasing the incidence of conversion to general anesthesia during TAVI procedure

Conditions

Aortic Stenosis

Outcome Measures

Primary Outcomes (1)

• 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

  Six months

Study Arms (3)

Group I (F)

ACTIVE COMPARATOR

suprainguinal fascia iliaca block group (SIFIB)

Other: suprainguinal fascia iliaca block group (SIFIB)

Group II (I)

ACTIVE COMPARATOR

iliohypogastric and ilioinguinal group (IL-IH)

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

Other: Local infiltration

Interventions

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.

Group I (F)

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).

Group II (I)

Local infiltration OTHER

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

Group III (C)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• younger than 20 years

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams university

Cairo, Egypt

Location

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesia, ICU and pain management

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: April 4, 2025
• Study Start: March 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)