Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

Not Applicable

Completed

• Conditions: Chronic Lower Limb Ischemia
• Interventions: Drug: Fascia iliaca block (FIB); Other: Spinal anesthesia

• Registration Number: NCT03798834
• Lead Sponsor: Mansoura University

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-17
• Study First Submitted: 2019-01-08
• Study First Submitted QC: 2019-01-08
• Study First Posted: 2019-01-10
• Primary Completion: 2019-02-01
• Study Completion: 2019-04-15
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-19
• Last Update Posted: 2020-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

Inclusion Criteria

• ASA physical status I or II.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fascia iliaca block (FIB)	Fascia iliaca block (FIB)	ultrasound-guided Fascia iliaca block
Spinal anesthesia	Spinal anesthesia	Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Primary Outcome Measures

Name	Time	Method
The proportion of the patients who did not require conversion to general anesthesia	for 30 minutes

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mansoura University; 🇪🇬 Mansourah, DK, Egypt