UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018308 |
|---|---|
| Receipt number | R000021191 |
| Scientific Title | efficacy of low-dose ketamine intravenous injection under nerve root block |
| Date of disclosure of the study information | 2015/07/15 |
| Last modified on | 2019/02/13 16:58:48 |
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Basic information
Public title
efficacy of low-dose ketamine intravenous injection under nerve root block
Acronym
efficacy of low-dose ketamine intravenous injection under nerve root block
Scientific Title
efficacy of low-dose ketamine intravenous injection under nerve root block
Scientific Title:Acronym
efficacy of low-dose ketamine intravenous injection under nerve root block
Region
| Japan |
Condition
Condition
neuropathic pain
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
efficacy of low-dose ketamine intravenous injection for neuropathic pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain score(visual analogue scale)
Hospital Anxiety and Depression Scale
PDAS
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
ketamine0.1mg/kg+saline100ml iv
Interventions/Control_2
ketamine0.3mg/kg+saline100ml iv
Interventions/Control_3
saline 100ml iv
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients to plan nerve root block
Key exclusion criteria
Alcoholism
Patients concurrently treated with beta-blocker
Patients with a history of allergy to ketamine
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiaki Minami |
Organization
Osaka medical college
Division name
Department of anesthesiology
Zip code
Address
2-7 daigaku-machi Takatsuki-city Osaka Japan
TEL
072-683-1221
ane022@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Hyoda |
Organization
Osaka medical college
Division name
Department of anesthesiology
Zip code
Address
2-7 daigaku-machi Takatsuki-city Osaka Japan
TEL
072-683-1221
Homepage URL
a-hyoda@qg7.so-net.ne.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Osaka medical college
Department of anesthesiology
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
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
大阪医科大学付属病院（大阪府）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 15 | 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
| 2015 | Year | 07 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 11 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2019 | Year | 02 | Month | 07 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 07 | Month | 14 | Day |
Last modified on
| 2019 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021191
