Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

Chronic Lower Limb Ischemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03798834
• Other study ID #: R/17.07.111
• Status: Completed
• Phase: N/A
• Start date: November 17, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: September 2020
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: April 15, 2019
• Est. primary completion date: February 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lower Limb Ischemia
• Ischemia

Intervention

Drug:
• Fascia iliaca block (FIB)
ultrasound-guided Fascia iliaca block

Other:
• Spinal anesthesia
Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Locations

Country	Name	City	State
Egypt	Mansoura University	Mansourah	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of the patients who did not require conversion to general anesthesia		for 30 minutes
Secondary	Postoperative pain	The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)	For 24 hours after the intervention
Secondary	Heart rate	changes in Heart rate	For 6 hours after the intervention
Secondary	mean arterial pressure (MAP	changes in mean arterial pressure (MAP	For 6 hours after the intervention
Secondary	hypotension	Incidents of hypotension	For 24 hours from the block
Secondary	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
Secondary	bradycardia	Incidents if bradycardia	For 24 hours from the block