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Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

M

Mansoura University

Status

Completed

Conditions

Chronic Lower Limb Ischemia

Treatments

Other: Spinal anesthesia
Drug: Fascia iliaca block (FIB)

Study type

Interventional

Funder types

Other

Identifiers

NCT03798834
R/17.07.111

Details and patient eligibility

About

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.

Full 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.

Enrollment

112 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

112 participants in 2 patient groups, including a placebo group

Fascia iliaca block (FIB)
Experimental group
Description:
ultrasound-guided Fascia iliaca block
Treatment:
Drug: Fascia iliaca block (FIB)
Spinal anesthesia
Placebo Comparator group
Description:
Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
Treatment:
Other: Spinal anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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