Fascia Iliaca Compartment Block for Proximal-end Femur Fractures

NCT ID: NCT02696915

Last Updated: 2016-03-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2015-08-31

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.

Conditions

Proximal Femur Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Ultrasound guided fascia iliaca compartment block

Intervention Type: DEVICE

Ultrasound guided fascia iliaca compartment block

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

Intervention Type: DRUG

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

Bupivacaine

Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Ultrasound guided fascia iliaca compartment block

Intervention Type: DEVICE

Ultrasound guided fascia iliaca compartment block

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

Intervention Type: DRUG

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

Interventions

Placebo

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

Intervention Type: DRUG

Bupivacaine

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

Intervention Type: DRUG

Ultrasound guided fascia iliaca compartment block

Ultrasound guided fascia iliaca compartment block

Intervention Type: DEVICE

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

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

Intervention Type: DRUG

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Reem A El Sharkawy, MD

Role: STUDY_CHAIR

Lecturer of Anesthesia and Surgical Intensive Care

Locations

Mansoura University Hospitals

Al Mansurah, DK, Egypt

Countries

Egypt

References

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.

Reference Type: DERIVED

PMID: 33238043 (View on PubMed)

Other Identifiers

MS/811

Identifier Type: -

Identifier Source: org_study_id