Proximal Femur FracturesNCT02696915
Fascia Iliaca Compartment Block for Proximal-end Femur Fractures
A study testing Bupivacaine, Ultrasound guided fascia iliaca compartment block and Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms) in people with Proximal Femur Fractures, run by Mansoura University at 1 site in Egypt.
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… Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Proximal Femur Fractures
- What is being tested?
- Bupivacaine, Ultrasound guided fascia iliaca compartment block and Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2015to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist physical status I to III
- Patients scheduled for fixation for proximal end femur fracture
Who cannot join
- Patients refusal
- Morbid obese patients (BMI>40)
- Bleeding diathesis
- Previous femoral bypass surgery
- Inguinal hernia
- Inflammation/infection over injection site
Show all 11Show fewer
- Peripheral neuropathy
- Allergy to local anesthetics agents used.
- Severely altered consciousness level
- Psychiatric disorders
- Polytrauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Being tested
- Placebo, Bupivacaine, Ultrasound guided fascia iliaca compartment block, Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)
- Medical subject headings
- Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
BupivacaineDrug
Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml
Ultrasound guided fascia iliaca compartment blockDevice
Ultrasound guided fascia iliaca compartment block
Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)Drug
Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered. Receives: Drug: Placebo; Device: Ultrasound guided fascia iliaca compartment block; Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms) |
| Bupivacaine | Active comparator | Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered. Receives: Drug: Bupivacaine; Device: Ultrasound guided fascia iliaca compartment block; Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scores
Pain was assessed using visual analogue score
Measured: For 24 hours after performance the blockade
Secondary outcomes (9)
Heart rate
Measured: For 24 hours after performance the blockade
Blood pressure
Measured: For 24 hours after performance the blockade
Peripheral oxygen saturation
Measured: 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
Measured: For 30 min after placement of patient in the optimum position
Number of trials of dural puncture
Measured: For 30 min after placement of patient in the optimum position
Duration of motor blockade
Measured: For 12 hours after performing spinal anesthesia
Duration of sensory blockade
Measured: For 12 hours after performing spinal anesthesia
Duration of analgesia
Time from performing spinal anesthesia to first analgesic request
Measured: For 24 hours after performing spinal anesthesia
Cumulative consumption of analgesics
Total opioid or other analgesics received for the first 24 hours after surgery.
Measured: For 24 hours after performing spinal anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2016 (estimated)
- Study startJan 2015
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Proximal Femur FracturesStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem A El Sharkawy, MD, Study chair, Lecturer of Anesthesia and Surgical Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02696915
- Sponsor's protocol ID
- MS/811
- Status last verified
- Mar 2016
- First submitted
- 22 Feb 2016
- Last updated
- 8 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
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.
PubMed 33238043
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fascia Iliaca Compartment Block in Proximal End Femur Fractures, Does it Make a Difference?
- ClinicalTrials.gov ID
- NCT02696915
- Acronym / sponsor ID
- MS/811
- Conditions
- Proximal Femur Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 2 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo, Device: Ultrasound guided fascia iliaca compartment block, Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)Patients received ultrasound guided fascia iliaca compartment block using 40 ml of saline 0.9%. Then intrathecal medications will be administered. |
| Bupivacaine | Active comparator | Drug: Bupivacaine, Device: Ultrasound guided fascia iliaca compartment block, Drug: Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)Patients received ultrasound guided fascia iliaca compartment block using 40 ml of 0.25% bupivacaine. Then intrathecal medications will be administered. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist physical status I to III
- Patients scheduled for fixation for proximal end femur fracture
Key exclusion criteria (11 listed)
- Patients refusal
- Morbid obese patients (BMI>40)
- Bleeding diathesis
- Previous femoral bypass surgery
- Inguinal hernia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPatients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml | Drug | Placebo |
| BupivacainePatients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml | Drug | Bupivacaine |
| Ultrasound guided fascia iliaca compartment blockUltrasound guided fascia iliaca compartment block | Device | Bupivacaine, Placebo |
| Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms | Drug | Bupivacaine, Placebo |
Primary outcome
Pain scores
Time frame: For 24 hours after performance the blockade
Pain was assessed using visual analogue score
9 secondary outcomes
Heart rate
Time frame: For 24 hours after performance the blockade
Blood pressure
Time frame: For 24 hours after performance the blockade
Peripheral oxygen saturation
Time frame: For 24 hours after performance the blockade
Time to performing spinal anesthesia
Time frame: For 30 min after placement of patient in the optimum position
Number of trials of dural puncture
Time frame: For 30 min after placement of patient in the optimum position
Duration of motor blockade
Time frame: For 12 hours after performing spinal anesthesia
Duration of sensory blockade
Time frame: For 12 hours after performing spinal anesthesia
Duration of analgesia
Time frame: For 24 hours after performing spinal anesthesia
Cumulative consumption of analgesics
Time frame: For 24 hours after performing spinal anesthesia
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Derived from this study: PubMed 33238043Guay 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Reem A El Sharkawy, MD study chair
Lecturer of Anesthesia and Surgical Intensive Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine, Ultrasound guided fascia iliaca compartment block and Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms) in people with Proximal Femur Fractures, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain scores (time frame: For 24 hours after performance the blockade). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02696915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.