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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000028620
Receipt No. R000031251
Scientific Title The effect of eutectic mixture lidocaine-propitocaine cream for patients who are scheduled cesarean section under epidural block
Date of disclosure of the study information 2017/08/10
Last modified on 2019/09/05

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Basic information
Public title The effect of eutectic mixture lidocaine-propitocaine cream for patients who are scheduled cesarean section under epidural block
Acronym The effect of eutectic mixture lidocaine-propitocaine cream for epidural block for cesarean section
Scientific Title The effect of eutectic mixture lidocaine-propitocaine cream for patients who are scheduled cesarean section under epidural block
Scientific Title:Acronym The effect of eutectic mixture lidocaine-propitocaine cream for epidural block for cesarean section
Region
Japan

Condition
Condition cesarean section
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the analgesic effects and safety of the eutectic mixture lidocaine- propitocaine cream for epidural block in the patients scheduled cesarean section.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Pain score using VAS at epidural block
Key secondary outcomes body movement at epidural block
duration time during epidural block
patient satisfaction

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 Device,equipment
Interventions/Control_1 1-2 hours befour epidural puncture, waserin was inplied to the site of epidural puncture
Interventions/Control_2 1-2 hours befour epidural puncture, the eutectic mixture lidocaine-propitocaine cream was applied to the site of epidural puncture
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
45 years-old >=
Gender Female
Key inclusion criteria ASA2
Key exclusion criteria Allergy of lidocaine
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Katsushi
Middle name
Last name Doi
Organization Hamada Medical Center
Division name Anesthesiology
Zip code 6978511
Address 777-12 Asai-cho, Hamada Medical Center
TEL 0855-25-0505
Email kdoiepi@gmail.com

Public contact
Name of contact person
1st name Katsushi
Middle name
Last name Doi
Organization Hamada Medical Center
Division name Anesthesiology
Zip code 6978511
Address 777-12 Asai-cho, Hamada, Shimane
TEL 0855-25-0505
Homepage URL
Email kdoiepi@gmail.com

Sponsor
Institute Hamada Medical Center
Institute
Department

Funding Source
Organization Hamada Medical Center
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 Hamada Medical Center
Address 777-12 Asai-cho, Hamada, Shimane
Tel 0855250505
Email 6103sy01@hamada2.hosp.go.jp

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 08 Month 10 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 Main results already published
Date of protocol fixation
2017 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 10 Day
Last follow-up date
2018 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 10 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031251

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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