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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000031760
Receipt No. R000036251
Scientific Title Effect of corticosteroid injection after nerve block on blood sugar level
Date of disclosure of the study information 2018/04/04
Last modified on 2018/09/14

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Basic information
Public title Effect of corticosteroid injection after nerve block on blood sugar level
Acronym Effect of dexamethasone on blood sugar
Scientific Title Effect of corticosteroid injection after nerve block on blood sugar level
Scientific Title:Acronym Effect of dexamethasone on blood sugar
Region
Japan

Condition
Condition lumbar radiculopathy, lumbar facet disease
Classification by specialty
Orthopedics Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Steroid elevates blood sugar level. We Investigate effect of dexamethasone local injection after lumbar radicular nerve block or lumbar facet block on blood sugar level.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Maximum blood sugar value after dexamethasoneinjection.
Key secondary outcomes Percentage of patients whose blood sugar level exceeds 200 mg/ml

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
80 years-old >
Gender Male and Female
Key inclusion criteria In anesthesiology and pain medicine of Gifu University Hospital, patients who are scheduled lumbar nerve root pulse high frequency or lumbar facet radiofrequency thermocoagulation, followed by administering dexamethasone hormone local injection.
Key exclusion criteria Patients who do not obtain consent.
Patients who the doctor judged unsuitable for dexamethasone administration such as severe diabetes.
Patients who received steroids within 1 month
Patient planned to receive image diagnosis except ultrasound.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kumiko Tanabe
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Yanagido 1-1, Gifu City
TEL 048-230-6404
Email kumiko-t@m2.gyao.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kumiko Tanabe
Organization Gifu University Graduate School of Medicine
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address Yanagido 1-1, Gifu City
TEL 048-230-6404
Homepage URL
Email kumiko-t@m2.gyao.ne.jp

Sponsor
Institute Gifu University Graduate School of Medicine
Institute
Department

Funding Source
Organization Gifu University Graduate School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 04 Month 04 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2018 Year 04 Month 04 Day
Date of IRB
Anticipated trial start date
2018 Year 04 Month 04 Day
Last follow-up date
2018 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Changes in blood glucose level after steroid administration are continuously measured.
Investigation of the time to reach the maximum blood sugar level, the highest blood sugar level, the ratio of the number of patients exceeded 200 mg / ml.

Management information
Registered date
2018 Year 03 Month 16 Day
Last modified on
2018 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036251

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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