Femoral Neck FracturesNCT06088368
Lumbar Plexus Block Application in Ultrasound-guided Shamrock Method
A study testing in-plane needle guidance and out-of-plane needle guidance in people with Femoral Neck Fractures and Lumbosacral Plexus, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Femoral Neck Fractures, Lumbosacral Plexus, Nerve Block
- What is being tested?
- in-plane needle guidance and out-of-plane needle guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Oct 2023to 13 Feb 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years old
- ASA (American Society of Anaesthesiologist) Score I-III risk class
- Patients who will undergo femoral neck fracture operation.
Who cannot join
- Local Anaesthetic Allergy
- With Bleeding Diathesis Disorder
- Mental Disorders
- Allergic to the medicines used
- Previous Cerebrovascular Disease
- Body Mass Index above 30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences,,Bursa Yuksek Ihtisas Training and Research Hospital,
Bursa
About this study
Official title: Investigation of the Efficacy of Different Types of Lumbar Plexus Block Applied With Ultrasound-guided Shamrock Method
The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging.
Read the detailed description
The purpose of this use is to investigate the effectiveness of lumbar plexus block application applied with in-plane and out-of-plane methods accompanied by Shamrock imaging.
- Conditions
- Femoral Neck Fractures, Lumbosacral Plexus, Nerve Block
- Being tested
- in-plane needle guidance, out-of-plane needle guidance
- Medical subject headings
- Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in-plane needle guidanceProcedure or surgery
Ultrasound -guided lumbar plexus block with in-plane needle guidance using the Shamrock method
out-of-plane needle guidanceProcedure or surgery
Ultrasound -guided lumbar plexus block with out-of-plane needle guidance using Shamrock method
| Study group | Role | What they receive |
|---|---|---|
| in-plane needle guidance | Active comparator | Ultrasound -guided lumbar plexus block Receives: Procedure: in-plane needle guidance |
| out-of-plane needle guidance | Active comparator | Ultrasound -guided lumbar plexus block Receives: Procedure: out-of-plane needle guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Block application time
The stopwatch will be started by another researcher with the needle skin penetration and the stopwatch will be stopped as soon as the needle leaves the skin.
Measured: up to 20 minutes
Secondary outcomes (4)
Number of interventions
intervention from the same or another site after exiting the skin
Measured: up to 20 minutes
The number of needle guidance
Retraction and re-advancement of the needle after skin entry without exiting the skin
Measured: up to 20 minutes
sensory block
Both lower limbs sensory block time after the applied block will be evaluated by pinprick and cold test (10.15., 20., 25., 30., 35. and 40 minutes).
Measured: up to 40 minutes
motor block
Both lower limbs Modified Bromage scale was used to evaluate motor block. Modified Bromage scale 0 No motor block
- Raises the knee in flexion
- Raises the ankle
- Full block, can't move his foot
Measured: up to 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start20 Oct 2023 (estimated)
- Primary completion25 Jan 2024 (estimated)
- Study completion13 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Neck FracturesStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Korgün Ökmen, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Korgün Ökmen, Assoc. PhD., Principal investigator, Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06088368
- Sponsor's protocol ID
- 2023-3/7
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Efficacy of Different Types of Lumbar Plexus Block Applied With Ultrasound-guided Shamrock Method
- ClinicalTrials.gov ID
- NCT06088368
- Acronym / sponsor ID
- 2023-3/7
- Conditions
- Femoral Neck Fractures, Lumbosacral Plexus, Nerve Block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 20 Oct 2023 (estimated)
- Primary completion
- 25 Jan 2024 (estimated)
- Study completion
- 13 Feb 2024 (estimated)
- First posted
- 18 Oct 2023 (actual)
- 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.
The more effective use of ultrasound in regional anaesthesia techniques has made different block applications possible. Lumbar plexus block is also used for post-operative analgesia and surgical anaesthesia. Currently, in-plane ultrasound-guided LPB is widely used in short-axis imaging and Shamrock imaging.
Detailed description
The purpose of this use is to investigate the effectiveness of lumbar plexus block application applied with in-plane and out-of-plane methods accompanied by Shamrock imaging.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in-plane needle guidance | Active comparator | Procedure: in-plane needle guidanceUltrasound -guided lumbar plexus block |
| out-of-plane needle guidance | Active comparator | Procedure: out-of-plane needle guidanceUltrasound -guided lumbar plexus block |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-90 years old
- ASA (American Society of Anaesthesiologist) Score I-III risk class
- Patients who will undergo femoral neck fracture operation.
Key exclusion criteria (6 listed)
- Local Anaesthetic Allergy
- With Bleeding Diathesis Disorder
- Mental Disorders
- Allergic to the medicines used
- Previous Cerebrovascular Disease
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 |
|---|---|---|
| in-plane needle guidanceUltrasound -guided lumbar plexus block with in-plane needle guidance using the Shamrock method | Procedure or surgery | in-plane needle guidance |
| out-of-plane needle guidanceUltrasound -guided lumbar plexus block with out-of-plane needle guidance using Shamrock method | Procedure or surgery | out-of-plane needle guidance |
Primary outcome
Block application time
Time frame: up to 20 minutes
The stopwatch will be started by another researcher with the needle skin penetration and the stopwatch will be stopped as soon as the needle leaves the skin.
4 secondary outcomes
Number of interventions
Time frame: up to 20 minutes
The number of needle guidance
Time frame: up to 20 minutes
sensory block
Time frame: up to 40 minutes
motor block
Time frame: up to 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
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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.
Korgün Ökmen, Assoc. PhD. principal investigator
Sağlık Bilimleri Üniversitesi Bursa Yüksek İhtisas Eğitim Ve Araştırma Hastanesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing in-plane needle guidance and out-of-plane needle guidance in people with Femoral Neck Fractures and Lumbosacral Plexus, run by Bursa Yuksek Ihtisas Training and Research Hospital at 1 site in Turkey (Türkiye).
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Oct 2023. 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 Turkey (Türkiye). 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Korgün Ökmen, Assoc. PhD. (+902242955000, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Block application time (time frame: up to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Oct 2023.