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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035139
Receipt No. R000040053
Official scientific title of the study Analgesic effect evaluation of nerve block during general anesthesia using pupillometry ~ Pilot study ~
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/05

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Basic information
Official scientific title of the study Analgesic effect evaluation of nerve block during general anesthesia using pupillometry ~ Pilot study ~
Title of the study (Brief title) Analgesic effect evaluation of nerve block during general anesthesia using pupillometry ~ Pilot study ~
Region
Japan

Condition
Condition knee osteoarthritis
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Pupillometry to detect pain response during general anesthesia for evaluation of analgesic effect of nerve block has been reported.
In this study, we analyze the change in pupil diameter after femoral nerve block, and investigate and analyze useful index for analgesic effect determination.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes time of determination of analgesic effect of nerve block by pupillometry
Key secondary outcomes change in pupil diameter, reaction latency, reaction rate

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients aged 20 years or older who undergo femoral nerve block during general anesthesia
Key exclusion criteria Patients with pupillary dysfunction
Patients with ophthalmic nerve paralysis
Patients using opioids before surgery
Patients using drugs affect pupil diameter change(anticholinergics, dopamine D2 receptor antagonists)
Patients who can not use propofol
Target sample size 10

Research contact person
Name of lead principal investigator Miho Wakabayashi
Organization Wakayama medical university
Division name department of anesthesiology
Address 811-1 Kimiidera, Wakayama-city, Wakayama, Japan
TEL 073-441-0611
Email mmasaki@wakayama-med.ac.jp

Public contact
Name of contact person Miho Wakabayashi
Organization Wakayama medical university
Division name department of anesthesiology
Address 811-1 Kimiidera, Wakayama-city, Wakayama, Japan
TEL 073-441-0611
Homepage URL
Email mmasaki@wakayama-med.ac.jp

Sponsor
Institute Wakayama medical university, department of anesthesiology
Institute
Department

Funding Source
Organization Wakayama medical university, department of anesthesiology
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 05 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 12 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 05 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information After administration of propofol, ultrasound-guided femoral nerve block is performed and electrical stimulation is performed to an anterior surface of the knee. We measure pupil diameter before and after stimulation, before the administration of the local anesthetic solution, 1 minute, 3 minutes, 5 minutes, 10 minutes, 15 minutes after the administration of the local anesthetic solution.
Also, as a control, electrical stimulation is similarly applied to the anterior surface of the knee on the contralateral side, and pupil diameter are measured.

Management information
Registered date
2018 Year 12 Month 05 Day
Last modified on
2018 Year 12 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040053

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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