Changes of Regional Tissue Oxygenation Saturation After Successful Femoral Nerve Block
1 other identifier
observational
100
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2018
Shorter than P25 for all trials
1 active site
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
CompletedFirst Posted
Study publicly available on registry
November 27, 2018
CompletedStudy Start
First participant enrolled
November 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 10, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 10, 2019
CompletedMay 13, 2019
May 1, 2019
5 months
November 20, 2018
May 10, 2019
Conditions
Keywords
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.
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.
Interventions
Eligibility Criteria
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
Study Officials
- STUDY DIRECTOR
Xiangdong Chen, Doctor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
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