UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031760
Receipt number 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 2020/01/15 13:34:22

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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 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 or person

Institute

Gifu University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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