UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029137 |
|---|---|
| Receipt number | 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 21:44:42 |
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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
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
daguang521521@163.com
Sponsor or person
Institute
Department of Anesthesiology, General Hospital of Tianjin Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033059
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