NCT03753594

Brief Summary

Regional tissue oxygenation saturation has been shown to increase in innervated regions after sympathetic block. The aim of this prospective observational study was to evaluate the changes of regional tissue oxygenation saturation by near-infrared spectroscopy after successful femoral nerve block with ropivacaine and determine whether the changes of regional tissue oxygenation saturation can be affected by the concentration of ropivacaine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 27, 2018

Completed
3 days until next milestone

Study Start

First participant enrolled

November 30, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2019

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

5 months

First QC Date

November 20, 2018

Last Update Submit

May 10, 2019

Conditions

Keywords

Peripheral nerve block

Outcome Measures

Primary Outcomes (1)

  • Regional tissue oxygenation saturation after successful femoral nerve block

    rSO2

    at 5-minute intervals till 30 minutes after regional block

Secondary Outcomes (1)

  • Pinprick sensory scores

    5 minute before regional block and at 5-minute intervals till 30 minutes after regional block

Study Arms (2)

H group

Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.5% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests at 5 min were assessed before the block and at 5-min intervals till 30 min after the block.

Device: tissue oxygenation saturation

L group

Patients scheduled for elective knee arthroscopy with peripheral nerve block will receive ultrasound-guided femoral nerve block with 0.25% ropivacaine. Regional tissue oxygenation saturation of the nerve innervation area and pinprick sensory tests were assessed at 5 min before the block and at 5-min intervals till 30 min after the block.

Device: tissue oxygenation saturation

Interventions

tissue oxygenation saturation

H groupL group

Eligibility Criteria

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

One hundred adult patients scheduled for elective knee arthroscopy with peripheral nerve block

You may qualify if:

  • Informed consent
  • American Society of Anesthesiologists physical statusⅠ-Ⅱ
  • Undergo elective elective knee arthroscopy with peripheral nerve block

You may not qualify if:

  • Refusal to participate in the study
  • BMI\>35
  • 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)

Union Hospital

Wuhan, Hubei, China

Location

Study Officials

  • Xiangdong Chen, Doctor

    Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Department of Anesthesiology, Union Hospital of Tongji Medical College

Study Record Dates

First Submitted

November 20, 2018

First Posted

November 27, 2018

Study Start

November 30, 2018

Primary Completion

May 10, 2019

Study Completion

May 10, 2019

Last Updated

May 13, 2019

Record last verified: 2019-05

Locations