Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy

Ultrasound-Guided Fascia Iliaca Compartmental Block Versus Spinal Anesthesia in Femoral Thrombectomy: a Randomized Double-Blind Study

This study aims to assess the efficiency of Fascia Iliaca Compartmental Block in patients undergoing femoral thrombectomy versus spinal anesthesia.

Study Overview

• Status: Completed
• Conditions: Spinal Anesthesia; Fascia Iliaca Compartmental Block; Femoral Thrombectomy
• Intervention / Treatment: Drug: ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ); Drug: Spinal Anesthesia (bupivacaine)

Detailed Description

Anesthesia for lower limb revascularization consists of general anesthesia, neuraxial anesthesia and peripheral regional block. Fascia iliaca compartment block (FICB) is an anterior approach to the lumbar plexus and it blocks femoral nerve, LFCN, and limited numbers of nearby nerves such as ilioinguinal, genitor femoral.

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • New Damietta, Egypt
    • Mansoura university hosbital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• scheduled femoral thrombectomy,
• both sexes,
• aged between 40-65 years,
• American Society of Anesthesiologists (ASA) II-III. Patients Criteria:

Exclusion Criteria:

• ASA status Grade IV, patient
• refused to participate,
• patients with contraindications to neuraxial anesthesia, such as systemic infection or history of allergy to anesthetic drugs
• infection at the site of injection.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fascia iliaca group; The ultrasound-guided fascia iliaca compartment block (FICB) group included 42 patients who had a fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.	Drug: ultrasound guided fascia iliaca compartment block ( bupivacaine 0.25% ); Fascia iliaca compartment block by bupivacaine 0.25% in a total volume of 40 ml.
Active Comparator: spinal anesthesia; spinal anesthesia included 42 patients had spinal anesthesia with 2.5 ml bupivacaine 0.5%.	Drug: Spinal Anesthesia (bupivacaine); spinal anesthesia by 2.5 ml bupivacaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain score postoperative	visual analogue score (VAS), with a scale from 0 to 10	24 hours

Collaborators and Investigators

• Sponsor: Port Said University hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2017
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: December 18, 2024
• First Submitted That Met QC Criteria: December 18, 2024
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 18, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Visual Analogue Score; UltraSound Guided; Fascia Iliaca Compartmental Block,; Spinal Anesthesia,; Femoral Thrombectomy
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Bupivacaine
• Other Study ID Numbers: MS/17.10.109

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: Data will be made available upon publication of the study results in a peer-reviewed journal.
• IPD Sharing Access Criteria: Researchers and healthcare professionals conducting methodologically sound and ethically approved research
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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