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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035001
Receipt No. 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

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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
Email 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
Email seishiaihara@matsuyama.jrc.or.jp

Sponsor
Institute Matsuyama Red Cross Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039912

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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