- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03169517
Blood Flow Index as an Indicator of Successful Peripheral Nerve Block
Blood Flow Index as an Indicator of Successful Peripheral Nerve Block : A Prospective Observational Study Using Laser Speckle Contrast Imaging.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Hubei
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Wuhan, Hubei, China
- Tongji Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- informed consent
- American Society of Anesthesiologists physical statusⅠ-Ⅱ
- Undergo elective upper or lower limb surgery with peripheral nerve block
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at 5-min intervals till 30 min after regional block
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
blood flow index
Time Frame: 5 min before regional block and at 5-min intervals till 30 min after regional block
|
perfusion unit(PU)
|
5 min before regional block and at 5-min intervals till 30 min after regional block
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- TJMZK20170325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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