LaserNCT03169517
Blood Flow Index as an Indicator of Successful Peripheral Nerve Block
An observational study of Laser, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative measurements of regional blood flow. The aim of this prospective observational study was to evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether this novel optical technique can be used as a… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laser
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 27 May 2017to 4 Sep 2017
- Phase
- Observational
- 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 75 years
- All sexes
- Adult, Older adult
Study population: One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block
Who may be able to join
- informed consent
- American Society of Anesthesiologists physical statusⅠ-Ⅱ
- Undergo elective upper or lower limb surgery with peripheral nerve block
Who cannot join
- refusal to participate in the study
- peripheral vascular disease
- digit injury or deficiency
- colored or infected fingernails/toenails
- BMI>35
- those who had taken vasodilatory drugs before surgery
- preoperative analgesic medications
- Any contraindications to peripheral nerve block such as coagulation abnormalities, allergy to local anaesthetics, peripheral neuropathy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Flow Index as an Indicator of Successful Peripheral Nerve Block : A Prospective Observational Study Using Laser Speckle Contrast Imaging.
Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative measurements of regional blood flow. The aim of this prospective observational study was to evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether this novel optical technique can be used as a reliable indicator of successful blocks.
Read the detailed description
Methods: One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests before the block and at 5-min intervals till 30 min after the block. The sensitivity, specificity of LSCI as a diagnostic method will be determined by receiver operator characteristic analysis.
Clinical Implications: LSCI with quantitative data could be used as an indicator of successful blocks.
- Conditions
- Laser
- Keywords
- Peripheral nerve block, laser speckle contrast imaging, blood flow index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve block group | patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests at 5 min before the block and at 5-min intervals till 30 min after the block. |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic power of LSCI and pinprick sensory tests for predicting successful and failed blocks
sensitivity and specificity
Measured: at 5-min intervals till 30 min after regional block
Secondary outcomes (1)
blood flow index
perfusion unit(PU)
Measured: 5 min before regional block and at 5-min intervals till 30 min after regional block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start27 May 2017
- Primary completion4 Sep 2017
- Study completion4 Sep 2017
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 LaserStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Mei, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03169517
- Sponsor's protocol ID
- TJMZK20170325
- Status last verified
- Sep 2017
- First submitted
- 24 May 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patient's privacy
Publications
Wu X, Li J, Joypaul K, Bao WW, Wang D, Huang YJ, Li PC, Mei W. Blood flow index as an indicator of successful sciatic nerve block: a prospective observational study using laser speckle contrast imaging. Br J Anaesth. 2018 Oct;121(4):859-866. doi: 10.1016/j.bja.2018.05.065. Epub 2018 Jul 4.
PubMed 30236247
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Flow Index as an Indicator of Successful Peripheral Nerve Block : A Prospective Observational Study Using Laser Speckle Contrast Imaging.
- ClinicalTrials.gov ID
- NCT03169517
- Acronym / sponsor ID
- TJMZK20170325
- Conditions
- Laser
- Keywords
- Peripheral nerve block, laser speckle contrast imaging, blood flow index
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 27 May 2017 (actual)
- Primary completion
- 4 Sep 2017 (actual)
- Study completion
- 4 Sep 2017 (actual)
- First posted
- 30 May 2017 (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.
Laser speckle contrast imaging (LSCI) allows real-time, non-invasive, quantitative measurements of regional blood flow. The aim of this prospective observational study was to evaluate the blood flow changes by LSCI after peripheral nerve block and determine whether this novel optical technique can be used as a reliable indicator of successful blocks.
Detailed description
Methods: One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests before the block and at 5-min intervals till 30 min after the block. The sensitivity, specificity of LSCI as a diagnostic method will be determined by receiver operator characteristic analysis.
Clinical Implications: LSCI with quantitative data could be used as an indicator of successful blocks.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve block group | – | –patients scheduled for elective upper or lower limb surgery with peripheral nerve block will receive LSCI measurements and pinprick sensory tests at 5 min before the block and at 5-min intervals till 30 min after the block. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block
Key inclusion criteria (3 listed)
- informed consent
- American Society of Anesthesiologists physical statusⅠ-Ⅱ
- Undergo elective upper or lower limb surgery with peripheral nerve block
Key exclusion criteria (8 listed)
- refusal to participate in the study
- peripheral vascular disease
- digit injury or deficiency
- colored or infected fingernails/toenails
- BMI>35
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
diagnostic power of LSCI and pinprick sensory tests for predicting successful and failed blocks
Time frame: at 5-min intervals till 30 min after regional block
sensitivity and specificity
1 secondary outcome
blood flow index
Time frame: 5 min before regional block and at 5-min intervals till 30 min after regional block
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 6 Sep 2017.
- Derived from this study: PubMed 30236247Wu X, Li J, Joypaul K, Bao WW, Wang D, Huang YJ, Li PC, Mei W. Blood flow index as an indicator of successful sciatic nerve block: a prospective observational study using laser speckle contrast imaging. Br J Anaesth. 2018 Oct;121(4):859-866. doi: 10.1016/j.bja.2018.05.065. Epub 2018 Jul 4.
- Individual participant dataSharing planned: No. For patient's privacy
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laser, run by Huazhong University of Science and Technology at 1 site in China.
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 8 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 6 Sep 2017. 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 China. 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?
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?
diagnostic power of LSCI and pinprick sensory tests for predicting successful and failed blocks (time frame: at 5-min intervals till 30 min after regional block). 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 NCT03169517, 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 6 Sep 2017.