Clinical trial NCT02696915: Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
Official title: Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Proximal Femur Fractures
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2016-03-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain scores
timeFrame: For 24 hours after performance the blockade
Secondary outcomes:
measure: Heart rate
timeFrame: For 24 hours after performance the blockade
measure: Blood pressure
timeFrame: For 24 hours after performance the blockade
measure: Peripheral oxygen saturation
timeFrame: For 24 hours after performance the blockade
measure: Time to performing spinal anesthesia
timeFrame: For 30 min after placement of patient in the optimum position
measure: Number of trials of dural puncture
timeFrame: For 30 min after placement of patient in the optimum position
measure: Duration of motor blockade
timeFrame: For 12 hours after performing spinal anesthesia
measure: Duration of sensory blockade
timeFrame: For 12 hours after performing spinal anesthesia
measure: Duration of analgesia
timeFrame: For 24 hours after performing spinal anesthesia
measure: Cumulative consumption of analgesics
timeFrame: For 24 hours after performing spinal anesthesia
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospitals
state: DK
Study officials:
affiliation: Lecturer of Anesthesia and Surgical Intensive Care
name: Reem A El Sharkawy, MD
role: STUDY_CHAIR
References:
citation: Guay J, Kopp S. Peripheral nerve blocks for hip fractures in adults. Cochrane Database Syst Rev. 2020 Nov 25;11(11):CD001159. doi: 10.1002/14651858.CD001159.pub3.