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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026790
Receipt No. R000030747
Scientific Title The effect of continuous epidural block in acute herpes zoster and post-herpetic neuralgia
Date of disclosure of the study information 2017/06/30
Last modified on 2017/08/02

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Basic information
Public title The effect of continuous epidural block in acute herpes zoster and post-herpetic neuralgia
Acronym The effect of continuous epidural block in zoster
Scientific Title The effect of continuous epidural block in acute herpes zoster and post-herpetic neuralgia
Scientific Title:Acronym The effect of continuous epidural block in zoster
Region
Asia(except Japan)

Condition
Condition patients with zoster associated pain
Classification by specialty
Medicine in general Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We aim to investigate whether continuous epidural block is effective for acute and chronic phase of herpes zoster.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes pain relief score (VAS reduction)
Key secondary outcomes complete remission rate, recurrence rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 epidural group: zoster patients received the current standard treatment for herpes and continuous epidural block for 14 days (continuous epidural block : continuous infusion of 4mL/h of 0.1% ropivacaine).
Interventions/Control_2 medical group: zoster patients received the current standard treatment for herpes (oral administration of 800 mg acyclovir, 1 times daily for 7 days if the rash had been present for less than 72 hour and analgesics as needed).
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 1) acute herpes zoster patients
2) PHN patients
Key exclusion criteria 1) past or current conditions that could affect the interpretation of the study results, safety, and subject participation including neurological, psychological, cardiac, hepatic, hematological, muscular, dermatological, or genital problems, cancer, or an immunocompromised state; 2) dermatological diseases other than PHN; 3) a medical history of a recent major procedure or surgery; 4) major pain with a cause other than PHN; 5) the presence of a medical device implanted for neuropathic pain such as a spinal cord stimulator, intrathecal pump, or peripheral nerve stimulator; 6) a medical history of spinal bone surgery, which could complicate catheter migration or application; 7) lactating or pregnant women; and 8) patients judged as inappropriate candidates for study participation by the investigator.
Target sample size 332

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sang Sik Choi
Organization Korea University Guro Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL 8226261870
Email clonidine@empal.com

Public contact
Name of contact person
1st name
Middle name
Last name Jung Eun Kim
Organization Korea University Guro Hospital
Division name Department of Anesthesiology and Pain Medicine
Zip code
Address 148, Gurodong-ro, Guro-gu, Seoul, Korea
TEL 8226261870
Homepage URL
Email geri200@gmail.com

Sponsor
Institute Korea University
Institute
Department

Funding Source
Organization Korea 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
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
2017 Year 06 Month 30 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
2008 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 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
2017 Year 03 Month 30 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030747

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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