Fascia Iliaca Block for Anesthesia in Lower Limb Thromboembolectomy

NCT ID: NCT03798834

Last Updated: 2020-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-17
• Study Completion Date: 2019-04-15

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.

Conditions

Chronic Lower Limb Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Fascia iliaca block (FIB)

ultrasound-guided Fascia iliaca block

Group Type: EXPERIMENTAL

Fascia iliaca block (FIB)

Intervention Type: DRUG

ultrasound-guided Fascia iliaca block

Spinal anesthesia

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Group Type: PLACEBO_COMPARATOR

Spinal anesthesia

Intervention Type: OTHER

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Interventions

Fascia iliaca block (FIB)

ultrasound-guided Fascia iliaca block

Intervention Type: DRUG

Spinal anesthesia

Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reem A Elsharkawy, MD

Role: STUDY_CHAIR

Lecturer of Anesthesia and Surgical Intensive Care

Locations

Mansoura University

Al Mansurah, DK, Egypt

Countries

Egypt

Other Identifiers

R/17.07.111

Identifier Type: -

Identifier Source: org_study_id