Nerve BlockNCT06126133
Evaluation of Lumbar Plexus Block Success With Near Infrared Spectroscopy (NIRS)
A study testing Near Infrared Spectroscopy in people with Nerve Block and Lumbar Plexus, run by Bursa Yuksek Ihtisas Training and Research Hospital.
Trial summary
Tests such as the pin-prick test, cold application or the Bromage scale are currently used to measure the success of nerve blocks and are considered subjective assessments as they require verbal consent from the patient. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nerve Block, Lumbar Plexus, Near Infrared Spectroscopy
- What is being tested?
- Near Infrared Spectroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 11 Nov 2023to 13 Jan 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
- femoral neck fracture,
- femoral shaft fracture,
- hip replacement surgery
- who will undergo velumbar plexus block will be included in the study.
Who cannot join
- BMI>40 kg/m2
- infection in the block area
- peripheral neuropathy,
- hemoglobinopathy
- peripheral vascular disease
- allergy to local anesthetics
- patients with contraindications for lumbar plexus block
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Near Infrared Spectroscopy (NIRS) Evaluation of Lumbar Plexus Block Success for Lower Extremity Orthopedic Surgery
Tests such as the pin-prick test, cold application or the Bromage scale are currently used to measure the success of nerve blocks and are considered subjective assessments as they require verbal consent from the patient.
Near Infrared Spectroscopy (NIRS) measures the differential absorption and reflection of near infrared light transmitted by human tissues, providing a tissue-oxygen saturation index. Modern NIRS-based instruments use multiple detectors to filter spectroscopy data from skin structures to detect subcutaneous tissue oxygenation.
Successful regional anesthesia results in decreased sympathetic activity within the distribution of blocked nerves. Regional oxygen saturation (rSO2) has been shown to increase in innervated areas after sympathetic block.
Read the detailed description
The aim of this study was to show whether the success of lumbar plexus block applied in lower extremity orthopedic surgeries can be evaluated by Near Infrared Spectroscopy (NIRS), which is used to measure tissue oxygenation.
- Conditions
- Nerve Block, Lumbar Plexus, Near Infrared Spectroscopy
- Being tested
- Near Infrared Spectroscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
Two NIRS probes will be attached to the extremity to be operated on and to the other lower extremity on the opposite side, at a level approximately coinciding with the midline above the quandriceps femoris muscle.
| Study group | Role | What they receive |
|---|---|---|
| Near İnfrared Spektroskopi (NIRS) | Experimental | Peripheral oxygen saturation to be measured with NIRS device Receives: Device: Near Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
rso2
The regional oxymetry probe will be placed in the the quandriceps femoris muscle, one on the extremity to be operated on and the other on the opposite lower extremity.
Measured: 40 minutes
Secondary outcomes (3)
sensory block level
The sensory block level will be realised by cold testing at 10 minute intervals after applying the block.
Measured: 40 minutes
blood pressure values
systolic, diastolic and mean blood pressure values will be recorded non-invasively in mmhg.
Measured: 40 minutes
so2
fingertip SO2 measured by pulse oximetry
Measured: 40 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start11 Nov 2023 (estimated)
- Primary completion25 Dec 2023 (estimated)
- Study completion13 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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, Bursa Yuksek Ihtisas Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06126133
- Sponsor's protocol ID
- 2022-6/5
- Status last verified
- Nov 2023
- First submitted
- 6 Nov 2023
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Near Infrared Spectroscopy (NIRS) Evaluation of Lumbar Plexus Block Success for Lower Extremity Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT06126133
- Acronym / sponsor ID
- 2022-6/5
- Conditions
- Nerve Block, Lumbar Plexus, Near Infrared Spectroscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bursa Yuksek Ihtisas Training and Research HospitalOther government
- Study start
- 11 Nov 2023 (estimated)
- Primary completion
- 25 Dec 2023 (estimated)
- Study completion
- 13 Jan 2024 (estimated)
- First posted
- 13 Nov 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.
Tests such as the pin-prick test, cold application or the Bromage scale are currently used to measure the success of nerve blocks and are considered subjective assessments as they require verbal consent from the patient.
Near Infrared Spectroscopy (NIRS) measures the differential absorption and reflection of near infrared light transmitted by human tissues, providing a tissue-oxygen saturation index. Modern NIRS-based instruments use multiple detectors to filter spectroscopy data from skin structures to detect subcutaneous tissue oxygenation.
Successful regional anesthesia results in decreased sympathetic activity within the distribution of blocked nerves. Regional oxygen saturation (rSO2) has been shown to increase in innervated areas after sympathetic block.
Detailed description
The aim of this study was to show whether the success of lumbar plexus block applied in lower extremity orthopedic surgeries can be evaluated by Near Infrared Spectroscopy (NIRS), which is used to measure tissue oxygenation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Near İnfrared Spektroskopi (NIRS) | Experimental | Device: Near Infrared SpectroscopyPeripheral oxygen saturation to be measured with NIRS device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-90 years old
- femoral neck fracture,
- femoral shaft fracture,
- hip replacement surgery
- who will undergo velumbar plexus block will be included in the study.
Key exclusion criteria (7 listed)
- BMI>40 kg/m2
- infection in the block area
- peripheral neuropathy,
- hemoglobinopathy
- peripheral vascular 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 |
|---|---|---|
| Near Infrared SpectroscopyTwo NIRS probes will be attached to the extremity to be operated on and to the other lower extremity on the opposite side, at a level approximately coinciding with the midline above the quandriceps femoris muscle. | Device | Near İnfrared Spektroskopi (NIRS) |
Primary outcome
rso2
Time frame: 40 minutes
The regional oxymetry probe will be placed in the the quandriceps femoris muscle, one on the extremity to be operated on and the other on the opposite lower extremity.
3 secondary outcomes
sensory block level
Time frame: 40 minutes
blood pressure values
Time frame: 40 minutes
so2
Time frame: 40 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 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
Bursa Yuksek Ihtisas Training and Research Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Near Infrared Spectroscopy in people with Nerve Block and Lumbar Plexus, run by Bursa Yuksek Ihtisas Training and Research Hospital.
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 5 inclusion and 7 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 14 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
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. (+905057081021, korgunokmen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rso2 (time frame: 40 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 14 Nov 2023.