UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028620 |
|---|---|
| Receipt number | 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 11:27:21 |
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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
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
kdoiepi@gmail.com
Sponsor or person
Institute
Hamada Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031251
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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