Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

Proximal Femur Fractures Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02696915
• Other study ID #: MS/811
• Status: Completed
• Phase: N/A
• First received: February 22, 2016
• Last updated: March 4, 2016
• Start date: January 2015
• Est. completion date: August 2015

Study information

• Verified date: March 2016
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Eduacaion
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone
• Proximal Femur Fractures

Intervention

Drug:
• Placebo
Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
• Bupivacaine
Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml

Device:
• Ultrasound guided fascia iliaca compartment block
Ultrasound guided fascia iliaca compartment block

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

Locations

Country	Name	City	State
Egypt	Mansoura University Hospitals	Mansoura	DK

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain scores	Pain was assessed using visual analogue score	For 24 hours after performance the blockade	No
Secondary	Heart rate		For 24 hours after performance the blockade	Yes
Secondary	Blood pressure		For 24 hours after performance the blockade	Yes
Secondary	Peripheral oxygen saturation		For 24 hours after performance the blockade	Yes
Secondary	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	No
Secondary	Number of trials of dural puncture		For 30 min after placement of patient in the optimum position	No
Secondary	Duration of motor blockade		For 12 hours after performing spinal anesthesia	No
Secondary	Duration of sensory blockade		For 12 hours after performing spinal anesthesia	No
Secondary	Duration of analgesia	Time from performing spinal anesthesia to first analgesic request	For 24 hours after performing spinal anesthesia	No
Secondary	Cumulative consumption of analgesics	Total opioid or other analgesics received for the first 24 hours after surgery.	For 24 hours after performing spinal anesthesia	No