Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

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

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

Study Overview

• Status: Completed
• Conditions: Proximal Femur Fractures
• Intervention / Treatment: Drug: Placebo; Device: Ultrasound guided fascia iliaca compartment block; Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms); Drug: Bupivacaine

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.	Drug: Placebo; Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 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
Active Comparator: Bupivacaine; Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.	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; Drug: Bupivacaine; Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Reem A El Sharkawy, MD, Lecturer of anesthesia and surgical intensive care

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: February 22, 2016
• First Submitted That Met QC Criteria: March 1, 2016
• First Posted (Estimate): March 2, 2016

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 4, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Femoral Fractures; Fractures, Bone; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Fentanyl; Bupivacaine
• Other Study ID Numbers: MS/811

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED