UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035001 |
|---|---|
| Receipt number | R000039912 |
| Scientific Title | Lidocaine-Propitocain Cream, A Form of Eutectic Mixture of Local Anesthetics (EMLA), Is an Effective Pain Relief on Vascular Access Intervention Therapy in Hemodialysis Patients: A Placebo-Controlled, Double-Blind, Crossover Study |
| Date of disclosure of the study information | 2018/11/27 |
| Last modified on | 2018/11/26 13:47:30 |
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Basic information
Public title
Lidocaine-Propitocain Cream, A Form of Eutectic Mixture of Local Anesthetics (EMLA), Is an Effective Pain Relief on Vascular Access Intervention Therapy in Hemodialysis Patients: A Placebo-Controlled, Double-Blind, Crossover Study
Acronym
Lidocaine-Propitocain Cream, A Form of Eutectic Mixture of Local Anesthetics (EMLA), Is an Effective Pain Relief on Vascular Access Intervention Therapy in Hemodialysis Patients: A Placebo-Controlled, Double-Blind, Crossover Study
Scientific Title
Lidocaine-Propitocain Cream, A Form of Eutectic Mixture of Local Anesthetics (EMLA), Is an Effective Pain Relief on Vascular Access Intervention Therapy in Hemodialysis Patients: A Placebo-Controlled, Double-Blind, Crossover Study
Scientific Title:Acronym
Lidocaine-Propitocain Cream, A Form of Eutectic Mixture of Local Anesthetics (EMLA), Is an Effective Pain Relief on Vascular Access Intervention Therapy in Hemodialysis Patients: A Placebo-Controlled, Double-Blind, Crossover Study
Region
| Japan |
Condition
Condition
Vascular access trouble
Classification by specialty
| Nephrology | Vascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Vascular access intervention therapy (VAIVT) is necessary to maintain vascular access in hemodialysis patients. Vasodilatation related to VAIVT is a painful procedure. However, few reports have been focusing on effective pain relief at the time of VAIVT. The present study examined whether Lidocaine-Propitocain cream, a form of eutectic mixture of local anesthetics (EMLA), effectively reduces pain on VAIVT in hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the degree of pain on VAIVT scored by visual analog scale (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
topical Lidocaine-Propitocain cream, a form of eutectic mixture of local anesthetics (EMLA)application
Interventions/Control_2
placebo
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
20 years old and over
Key exclusion criteria
AVG
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Oka Hideaki |
Organization
Matsuyama Red Cross Hospital
Division name
Kidney Center
Zip code
Address
1 Bunkyo-cho, Matsuyama-shi, Ehime 790-8524, Japan
TEL
0899241111
seishiaihara@matsuyama.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Oka Hideaki |
Organization
Matsuyama Red Cross Hospital
Division name
Kidney Center
Zip code
Address
1 Bunkyo-cho, Matsuyama-shi, Ehime 790-8524, Japan
TEL
0899241111
Homepage URL
seishiaihara@matsuyama.jrc.or.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2018 | Year | 11 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2017 | Year | 08 | 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
| 2018 | Year | 11 | Month | 26 | Day |
Last modified on
| 2018 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039912
