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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03169517
Other study ID # TJMZK20170325
Secondary ID
Status Completed
Phase N/A
First received May 24, 2017
Last updated September 4, 2017
Start date May 27, 2017
Est. completion date September 4, 2017

Study information

Verified date September 2017
Source Huazhong University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 reliable indicator of successful blocks.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date September 4, 2017
Est. primary completion date September 4, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- informed consent

- American Society of Anesthesiologists physical status?-?

- 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
China Tongji Hospital Wuhan Hubei

Sponsors (1)

Lead Sponsor Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary diagnostic power of LSCI and pinprick sensory tests for predicting successful and failed blocks sensitivity and specificity at 5-min intervals till 30 min after regional block
Secondary blood flow index perfusion unit(PU) 5 min before regional block and at 5-min intervals till 30 min after regional block
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