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Clinical Trials/NCT03798834
NCT03798834
Completed
Not Applicable

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

Mansoura University1 site in 1 country112 target enrollmentNovember 17, 2018

Overview

Phase
Not Applicable
Intervention
Fascia iliaca block (FIB)
Conditions
Chronic Lower Limb Ischemia
Sponsor
Mansoura University
Enrollment
112
Locations
1
Primary Endpoint
The proportion of the patients who did not require conversion to general anesthesia
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 17, 2018
End Date
April 15, 2019
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Arms & Interventions

Fascia iliaca block (FIB)

ultrasound-guided Fascia iliaca block

Intervention: Fascia iliaca block (FIB)

Spinal anesthesia

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Intervention: Spinal anesthesia

Outcomes

Primary Outcomes

The proportion of the patients who did not require conversion to general anesthesia

Time Frame: for 30 minutes

Secondary Outcomes

  • bradycardia(For 24 hours from the block)
  • Postoperative pain(For 24 hours after the intervention)
  • Heart rate(For 6 hours after the intervention)
  • mean arterial pressure (MAP(For 6 hours after the intervention)
  • hypotension(For 24 hours from the block)
  • Any observed adverse effects(over the 24 hours postoperative)

Study Sites (1)

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