Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Chronic Lower Limb Ischemia

Intervention / Treatment
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* Drug: Fascia iliaca block (FIB)
* Other: Spinal anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |