UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006531 |
|---|---|
| Receipt number | R000007561 |
| Scientific Title | Root Injection for Zoster associated pain comparing with Epidural injection |
| Date of disclosure of the study information | 2011/10/13 |
| Last modified on | 2011/10/13 00:54:56 |
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Basic information
Public title
Root Injection for Zoster associated pain comparing with Epidural injection
Acronym
Root block for Zoster associated pain
Scientific Title
Root Injection for Zoster associated pain comparing with Epidural injection
Scientific Title:Acronym
Root block for Zoster associated pain
Region
| Japan |
Condition
Condition
Herpes Zoster
Classification by specialty
| Neurology | Dermatology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison of the analgesic efficacy of a nerve root block or an epidural block for acute zoster associated pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Visual analogue scale after 1 month of the onset of herpes zoster
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Dexamethasone 1.65mg and 0.5% mepivacaine 4ml are injected twice by fluoroscopically guided epidural block.
Interventions/Control_2
Dexamethasone 1.65mg and 2% mepivacaine 1ml are injected twice by fluoroscopically guided root block.
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
| 60 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
herpes zoster below C6
within 14 days the onset of skin lesions
VAS: 40 or more
sufficiently master of Japanese language
Key exclusion criteria
severe herpes zoster (paralysis, dysuria, meningitis, generalized HZ)
diabetes (HbA1c:8.0% or more)
renal disorder (Cr:1.5 or more)
liver dysfunction (Chiled Class:B or more)
clotting defect incl. use of warfarin or antiplatelet agents
allergy of mepivacaine, dexamethasone or iohexol
bact. superinfection of skin above vertebra affect. derm.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Watanabe |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 Shijo-cho, Kashihara, Nara 634-8522, Japan
TEL
0744-22-3051
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
TEL
0744-22-3051
Homepage URL
Sponsor or person
Institute
Department of Anesthesiology
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology
Nara Medical University
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
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 13 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 13 | Day |
Last modified on
| 2011 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007561
