Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
Primary Purpose
Proximal Femur Fractures
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Placebo
Bupivacaine
Ultrasound guided fascia iliaca compartment block
Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Sponsored by
About this trial
This is an interventional treatment trial for Proximal Femur Fractures
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
Sites / Locations
- Mansoura University Hospitals
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Bupivacaine
Arm Description
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.
Outcomes
Primary Outcome Measures
Pain scores
Pain was assessed using visual analogue score
Secondary Outcome Measures
Heart rate
Blood pressure
Peripheral oxygen saturation
Time to performing spinal anesthesia
Time from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine
Number of trials of dural puncture
Duration of motor blockade
Duration of sensory blockade
Duration of analgesia
Time from performing spinal anesthesia to first analgesic request
Cumulative consumption of analgesics
Total opioid or other analgesics received for the first 24 hours after surgery.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02696915
Brief Title
Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
Official Title
Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Proximal Femur Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered.
Arm Title
Bupivacaine
Arm Type
Active Comparator
Arm Description
Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml
Intervention Type
Device
Intervention Name(s)
Ultrasound guided fascia iliaca compartment block
Intervention Description
Ultrasound guided fascia iliaca compartment block
Intervention Type
Drug
Intervention Name(s)
Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
Intervention Description
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
Primary Outcome Measure Information:
Title
Pain scores
Description
Pain was assessed using visual analogue score
Time Frame
For 24 hours after performance the blockade
Secondary Outcome Measure Information:
Title
Heart rate
Time Frame
For 24 hours after performance the blockade
Title
Blood pressure
Time Frame
For 24 hours after performance the blockade
Title
Peripheral oxygen saturation
Time Frame
For 24 hours after performance the blockade
Title
Time to performing spinal anesthesia
Description
Time from the placement of patient in the optimum position to the intra-thecal injection of bupivacaine
Time Frame
For 30 min after placement of patient in the optimum position
Title
Number of trials of dural puncture
Time Frame
For 30 min after placement of patient in the optimum position
Title
Duration of motor blockade
Time Frame
For 12 hours after performing spinal anesthesia
Title
Duration of sensory blockade
Time Frame
For 12 hours after performing spinal anesthesia
Title
Duration of analgesia
Description
Time from performing spinal anesthesia to first analgesic request
Time Frame
For 24 hours after performing spinal anesthesia
Title
Cumulative consumption of analgesics
Description
Total opioid or other analgesics received for the first 24 hours after surgery.
Time Frame
For 24 hours after performing spinal anesthesia
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reem A El Sharkawy, MD
Organizational Affiliation
Lecturer of Anesthesia and Surgical Intensive Care
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura University Hospitals
City
Mansoura
State/Province
DK
ZIP/Postal Code
050
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33238043
Citation
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.
Results Reference
derived
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Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
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