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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Aortic Stenosis
• Intervention / Treatment: Other: suprainguinal fascia iliaca block group (SIFIB); Other: iliohypogastric and ilioinguinal group (IL-IH); Other: Local infiltration

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (F); suprainguinal fascia iliaca block group (SIFIB)	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 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.
Active Comparator: Group II (I); iliohypogastric and ilioinguinal group (IL-IH)	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 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 III (C); 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; patients receive infiltration of 0.5% 10ml bupivacaine and 1% 10 ml lidocaine in the groin at the site of puncture.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2025
• Primary Completion (Estimated): August 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: March 22, 2025
• First Submitted That Met QC Criteria: April 3, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Actual): April 4, 2025
• Last Update Submitted That Met QC Criteria: April 3, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aortic Valve Disease; Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Ventricular Outflow Obstruction; Aortic Valve Stenosis
• Other Study ID Numbers: FMASU R30/2024/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No