Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Proximal Femur Fractures

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered. | Drug: Placebo<br>* Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml<br>Device: Ultrasound guided fascia iliaca compartment block<br>* Ultrasound guided fascia iliaca compartment block<br>Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)<br>* Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms<br>|
| Active Comparator: Bupivacaine<br>Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered. | Drug: Bupivacaine<br>* Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml<br>Device: Ultrasound guided fascia iliaca compartment block<br>* Ultrasound guided fascia iliaca compartment block<br>Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)<br>* Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores | Pain was assessed using visual analogue score | For 24 hours after performance the blockade | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | For 24 hours after performance the blockade | 
| Blood pressure |  | For 24 hours after performance the blockade | 
| Peripheral oxygen saturation |  | For 24 hours after performance the blockade | 
| Time to performing spinal anesthesia | Time from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine | For 30 min after placement of patient in the optimum position | 
| Number of trials of dural puncture |  | For 30 min after placement of patient in the optimum position | 
| Duration of motor blockade |  | For 12 hours after performing spinal anesthesia | 
| Duration of sensory blockade |  | For 12 hours after performing spinal anesthesia | 
| Duration of analgesia | Time from performing spinal anesthesia to first analgesic request | For 24 hours after performing spinal anesthesia | 
| Cumulative consumption of analgesics | Total opioid or other analgesics received for the first 24 hours after surgery. | For 24 hours after performing spinal anesthesia |