UMIN-CTR Clinical Trial

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 Kumiko Middle name Last name Tanabe
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	501-1194
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 Kumiko Middle name Last name Tanabe
Organization	Gifu University Graduate School of Medicine
Division name	Department of Anesthesiology and Pain Medicine
Zip code	501-1194
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	Gifu University Graduate School of Medicine
Address	Yanagido 1-1, Gifu City
Tel	058-230-6404
Email	kumiko-t@m2.gyao.ne.jp

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	Completed
Date of protocol fixation	2018 Year 04 Month 04 Day
Date of IRB	2018 Year 04 Month 04 Day
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	2020 Year 01 Month 15 Day

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