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Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02696915
Enrollment
60
Registered
2016-03-02
Start date
2015-01-31
Completion date
2015-08-31
Last updated
2016-03-08

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

Conditions

Proximal Femur Fractures

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.

Interventions

DRUGPlacebo

Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml

DRUGBupivacaine

Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml

DEVICEUltrasound guided fascia iliaca compartment block

Ultrasound guided fascia iliaca compartment block

DRUGIntrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)

Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms

Sponsors

Mansoura University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

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

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

Design outcomes

Primary

MeasureTime frameDescription
Pain scoresFor 24 hours after performance the blockadePain was assessed using visual analogue score

Secondary

MeasureTime frameDescription
Blood pressureFor 24 hours after performance the blockade
Peripheral oxygen saturationFor 24 hours after performance the blockade
Time to performing spinal anesthesiaFor 30 min after placement of patient in the optimum positionTime from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine
Number of trials of dural punctureFor 30 min after placement of patient in the optimum position
Heart rateFor 24 hours after performance the blockade
Duration of sensory blockadeFor 12 hours after performing spinal anesthesia
Duration of analgesiaFor 24 hours after performing spinal anesthesiaTime from performing spinal anesthesia to first analgesic request
Cumulative consumption of analgesicsFor 24 hours after performing spinal anesthesiaTotal opioid or other analgesics received for the first 24 hours after surgery.
Duration of motor blockadeFor 12 hours after performing spinal anesthesia

Countries

Egypt

Outcome results

None listed

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