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Blood Flow Index as an Indicator of Successful Peripheral Nerve Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03169517
Recruitment Status : Completed
First Posted : May 30, 2017
Last Update Posted : September 6, 2017
Sponsor:
Information provided by (Responsible Party):
Wei Mei, Huazhong University of Science and Technology

Brief 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 reliable indicator of successful blocks.

Condition or disease
Laser

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.

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Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Blood Flow Index as an Indicator of Successful Peripheral Nerve Block : A Prospective Observational Study Using Laser Speckle Contrast Imaging.
Actual Study Start Date : May 27, 2017
Actual Primary Completion Date : September 4, 2017
Actual Study Completion Date : September 4, 2017

Group/Cohort
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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. blood flow index [ Time Frame: 5 min before regional block and at 5-min intervals till 30 min after regional block ]
    perfusion unit(PU)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03169517


Locations
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China, Hubei
Tongji Hospital
Wuhan, Hubei, China
Sponsors and Collaborators
Huazhong University of Science and Technology
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Wei Mei, Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
ClinicalTrials.gov Identifier: NCT03169517    
Other Study ID Numbers: TJMZK20170325
First Posted: May 30, 2017    Key Record Dates
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For patient's privacy

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wei Mei, Huazhong University of Science and Technology:
Peripheral nerve block
laser speckle contrast imaging
blood flow index