Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

Mansoura University

Status: Completed

Conditions: Proximal Femur Fractures

Treatments: Drug: Bupivacaine; Drug: Placebo; Device: Ultrasound guided fascia iliaca compartment block; Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Study type: Interventional

Funder types: Other

Identifiers

NCT02696915

MS/811

Details and patient eligibility

About

Fracture femur is a common injury which is associated with excruciating pain. Positioning for neuraxial blocks is always challenging because even slight overriding of the fracture ends is intensely painful .It can causing major patient distress which accompanied by well-known physiological sequelae such as sympathetic activation causing tachycardia, hypotension, and increased cardiac work that may compromise high-risk cardiac patients.

Fascia iliaca compartment block is highly effective in blocking lateral cutaneous nerve of the thigh and femoral nerve. Fascia iliaca compartment block is not only easy to perform but it is also associated with minimal risk as the local anesthetic is injected at a safe distance from the femoral artery and femoral nerve. It is always safe to perform the fascia iliaca compartment block prior to spinal anesthesia as the patient can respond during administration of the local anesthetic and can prevent intra-neuronal injections

Full description

On arrival to the pre-operative holding area half hour before the scheduled surgery. Patient will be connected to basal monitoring devices; pulse oximetry and non- invasive blood pressure. Fascia iliaca compartment block will be performed with the aid of ultrasound device in all cases.The injected local anesthetic solution will be prepared by a staff member who was not involved in the study) according to the randomization. After 20 minutes from the injection the investigators will assessed nerves that had been blocked.

On arrival to the operative theater, under complete aseptic technique spinal anesthesia will be carried out in the sitting position (if there is severe pain at positioning we will use lateral position) at space between L3-4 or L4-5 using a 25-gauge spinal quincke needle. After feeling the desired space, the needle will be advanced (paramedian approach) till free flow of cerebrospinal fluid dropped from the needle then 15 mg hyperbaric bupivacaine+20mic fentanyl will be injected.

Enrollment: 60 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• American Society of Anesthesiologist physical status I to III
• Patients scheduled for fixation for proximal end femur fracture

Exclusion criteria

• Patients refusal
• Morbid obese patients (BMI>40)
• Bleeding diathesis
• Previous femoral bypass surgery
• Inguinal hernia
• Inflammation/infection over injection site
• Peripheral neuropathy
• Allergy to local anesthetics agents used.
• Severely altered consciousness level
• Psychiatric disorders
• Polytrauma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.

Treatment:

Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Drug: Placebo

Device: Ultrasound guided fascia iliaca compartment block

Bupivacaine

Active Comparator group

Description:

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.

Treatment:

Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Drug: Bupivacaine

Device: Ultrasound guided fascia iliaca compartment block