NCT03169517

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2017

Completed
3 days until next milestone

Study Start

First participant enrolled

May 27, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 4, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

3 months

First QC Date

May 24, 2017

Last Update Submit

September 4, 2017

Conditions

Keywords

Peripheral nerve blocklaser speckle contrast imagingblood flow index

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • blood flow index

    5 min before regional block and at 5-min intervals till 30 min after regional block

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

One hundred adult patients scheduled for elective upper or lower limb surgery with peripheral nerve block

You may qualify if:

  • informed consent
  • American Society of Anesthesiologists physical statusⅠ-Ⅱ
  • Undergo elective upper or lower limb surgery with peripheral nerve block

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

Location

Related Publications (1)

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice Director, Department of Anaesthesiology, Tongji Hospital of Tongji Medical College

Study Record Dates

First Submitted

May 24, 2017

First Posted

May 30, 2017

Study Start

May 27, 2017

Primary Completion

September 4, 2017

Study Completion

September 4, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

For patient's privacy

Locations