Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia

The fascia iliaca block (FIB) is an anterior approach to block the lumbar plexus. It disturbed mainly to the anterior region of the thigh by blocking the femoral nerve (LFC) and the lateral femoral cutaneous nerve. Moreover, FIB may possibly be extended to the obturator, ilioinguinal, genitofemoral, lateral cutaneous nerve of the thigh and over the psoas muscle but, rarely reaches the lumbar plexus.

The fascia iliaca compartment could be detected by bony landmarks palpation and the loss of resistance technique. Feeling two tactile ''pops'' due to loss of resistance occurred during the needle passage through the fascia lata and the fascia iliaca. Ultrasound (US) guidance of FIB will increase the success rate and the efficacy of sensory blockade by decreasing the needed local anesthetic amount.

Study Overview

• Status: Completed
• Conditions: Chronic Lower Limb Ischemia
• Intervention / Treatment: Drug: Fascia iliaca block (FIB); Other: Spinal anesthesia

Detailed Description

This study was conducted to demonstrate the success incidence (to evaluate the efficacy) of preoperative 0.25% bupivacaine FIB as a sole anesthetic technique in thromboembolectomy of unilateral chronic lower limb ischemia compared to neuraxial anesthesiaas a primary goal. Intraoperative hemodynamics variation, postoperative pain score, total analgesic rescue requests and the total amount of systemic rescue analgesia used in the first postoperative day in addition to any detected postoperative complications were secondary goals. The hypothesis is that; FIB will provide adequate anesthesia as neuraxial anesthesia.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansourah, DK, Egypt, 050
      • Mansoura University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ASA physical status I or II.

Exclusion Criteria:

• Patients with previous same lower limb surgery
• Neuromuscular disease
• Severe cardiovascular disease
• Any contraindications to regional anesthesia
• patient refusal
• coagulation abnormality
• Known allergy to local anesthetics
• Infection at the injection site

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fascia iliaca block (FIB); ultrasound-guided Fascia iliaca block	Drug: Fascia iliaca block (FIB); ultrasound-guided Fascia iliaca block
Placebo Comparator: Spinal anesthesia; Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%	Other: Spinal anesthesia; Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of the patients who did not require conversion to general anesthesia	for 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)	For 24 hours after the intervention
Heart rate	changes in Heart rate	For 6 hours after the intervention
mean arterial pressure (MAP	changes in mean arterial pressure (MAP	For 6 hours after the intervention
hypotension	Incidents of hypotension	For 24 hours from the block
Any observed adverse effects	ny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding	over the 24 hours postoperative
bradycardia	Incidents if bradycardia	For 24 hours from the block

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Reem A Elsharkawy, MD, Lecturer of Anesthesia and Surgical Intensive care

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2018
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: January 8, 2019
• First Submitted That Met QC Criteria: January 8, 2019
• First Posted (Actual): January 10, 2019

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Ischemia; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: R/17.07.111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No