Blood Flow Index as an Indicator of Successful Peripheral Nerve Block

September 4, 2017 updated by: Wei Mei, Huazhong University of Science and Technology

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.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders 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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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.

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

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2017

Primary Completion (Actual)

September 4, 2017

Study Completion (Actual)

September 4, 2017

Study Registration Dates

First Submitted

May 24, 2017

First Submitted That Met QC Criteria

May 25, 2017

First Posted (Actual)

May 30, 2017

Study Record Updates

Last Update Posted (Actual)

September 6, 2017

Last Update Submitted That Met QC Criteria

September 4, 2017

Last Verified

September 1, 2017

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)?

No

IPD Plan Description

For patient's privacy

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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