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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029137
Receipt No. R000033059
Scientific Title The evaluation of treatment effect of combined different drugs on herpes zoster neuralgia (PHN) via epidural block
Date of disclosure of the study information 2019/08/01
Last modified on 2017/09/13

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Basic information
Public title The evaluation of treatment effect of combined different drugs on herpes zoster neuralgia (PHN) via epidural block
Acronym The effect of combined different drugs on herpes zoster neuralgia (PHN) via epidural block
Scientific Title The evaluation of treatment effect of combined different drugs on herpes zoster neuralgia (PHN) via epidural block
Scientific Title:Acronym The effect of combined different drugs on herpes zoster neuralgia (PHN) via epidural block
Region
Asia(except Japan)

Condition
Condition Herpes zoster neuralgia
Classification by specialty
Medicine in general Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of combined different drugs on herpes zoster neuralgia (PHN) via epidural block
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the offect of pain variation effect different drugs on herpes zoster neuralgia (PHN)
Key secondary outcomes none

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Methylprednisolone80mg + 0.1%ropivacaine + sufentanil100ug+0.9%NaCl=400ml, continuous epidural injection for 8day
Interventions/Control_2 Methylprednisolone80mg + 0.1%ropivacaine + sufentanil100ug+ketamine100mg+0.9%NaCl=400ml, continuous epidural injection for 8day
Interventions/Control_3 Methylprednisolone80mg + 0.1%ropivacaine ++ketamine200mgg+0.9%NaCl=400ml, continuous epidural injection for 8day
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
50 years-old <
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria 1 older than 50 years inpatient, younger than 90 years inpatient
2 dermatome below C6
3 Moderate to serve pain(NRS baseline mort than 6 )persisting for more than 3 months after onset of herpes zoster rash
4 Uncontrollable pain by conventional drugs
5 Normal cognitive and communicative ability and ability to complete self-report questionnaires
Key exclusion criteria 1 patients with facial involvement
2 known sensitivity to methylprednisolone, ketamine,ropivacaine, and sufentanil
3 serious mental or psychiatric illness
4 Drug addiction and alcoholism
5 Bacterial infection of the skin overlying the vertebra of the affected dermatome
6 bronchial asthma, serve hypertension, serious cardiovascular disease, serve hepatic and renal dysfunction, serious hematological disease
7 patients participated in other clinical study in recent 6 months
8 Non-compliant patient who will not complete relative treatment and questionnaires.
9 Patients with any unsuitable situation decided by researchers will be excluded.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Guolin Wang
Organization Department of Anesthesiology, General Hospital of Tianjin Medical University
Division name General Hospital of Tianjin Medical University
Zip code
Address No.154 Anshan Street, Heping District, 300054 Tianjin, PR China
TEL +86-13662179014
Email wang_guolin@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hongguang Chen
Organization Department of Anesthesiology, General Hospital of Tianjin Medical University
Division name General Hospital of Tianjin Medical University
Zip code
Address No.154 Anshan Street, Heping District, 300054 Tianjin, PR China
TEL +86-13662179014
Homepage URL
Email daguang521521@163.com

Sponsor
Institute Department of Anesthesiology, General Hospital of Tianjin Medical University
Institute
Department

Funding Source
Organization Department of Anesthesiology, General Hospital of Tianjin 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
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 Tianjin Institute of Anesthesiology

Other administrative information
Date of disclosure of the study information
2019 Year 08 Month 01 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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 09 Month 13 Day
Last modified on
2017 Year 09 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033059

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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