Clinical trial NCT03798834: Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy
Official title: Fascia Iliaca Block as an Anesthetic Technique for Thromboembolectomy of Chronic Lower Limb Ischemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Lower Limb Ischemia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-01-10
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The proportion of the patients who did not require conversion to general anesthesia
timeFrame: for 30 minutes
Secondary outcomes:
measure: Postoperative pain
timeFrame: For 24 hours after the intervention
measure: Heart rate
timeFrame: For 6 hours after the intervention
measure: mean arterial pressure (MAP
timeFrame: For 6 hours after the intervention
measure: hypotension
timeFrame: For 24 hours from the block
measure: Any observed adverse effects
timeFrame: over the 24 hours postoperative
measure: bradycardia
timeFrame: For 24 hours from the block
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Reem A Elsharkawy, MD
role: STUDY_CHAIR
References: