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Completed

NCT Number: NCT03798834

Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

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.

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Key information

Conditions

Chronic Lower Limb Ischemia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University

Al Mansurah, DK, 050, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fascia iliaca block (FIB)

Drug

ultrasound-guided Fascia iliaca block

Spinal anesthesia

Other

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Primary outcomes

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

    Time frame: for 30 minutes

Secondary outcomes

  1. Postoperative pain

    Time frame: For 24 hours after the intervention

    The post-operative pain will recorded using 10-point Visual Analog Scale (VAS)

  2. Heart rate

    Time frame: For 6 hours after the intervention

    changes in Heart rate

  3. mean arterial pressure (MAP

    Time frame: For 6 hours after the intervention

    changes in mean arterial pressure (MAP

  4. hypotension

    Time frame: For 24 hours from the block

    Incidents of hypotension

  5. Any observed adverse effects

    Time frame: 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

  6. bradycardia

    Time frame: For 24 hours from the block

    Incidents if bradycardia

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 10, 2019
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.