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Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03798834
Enrollment
112
Registered
2019-01-10
Start date
2018-11-17
Completion date
2019-04-15
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lower Limb Ischemia

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.

Interventions

ultrasound-guided Fascia iliaca block

OTHERSpinal anesthesia

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The proportion of the patients who did not require conversion to general anesthesiafor 30 minutes

Secondary

MeasureTime frameDescription
Heart rateFor 6 hours after the interventionchanges in Heart rate
mean arterial pressure (MAPFor 6 hours after the interventionchanges in mean arterial pressure (MAP
Postoperative painFor 24 hours after the interventionThe post-operative pain will recorded using 10-point Visual Analog Scale (VAS)
Any observed adverse effectsover the 24 hours postoperativeny adverse effects will be observed over the 24 hours postoperative for local skin hematoma ,sensory deficits or local bleeding
bradycardiaFor 24 hours from the blockIncidents if bradycardia
hypotensionFor 24 hours from the blockIncidents of hypotension

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026