UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009939 |
|---|---|
| Receipt number | R000011643 |
| Scientific Title | Investigation of the optimum rate of patient controlled epidural analgesia after cesarean section |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2020/04/01 10:24:16 |
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Basic information
Public title
Investigation of the optimum rate of patient controlled epidural analgesia after cesarean section
Acronym
Investigation of the optimum rate of patient controlled epidural analgesia after cesarean section
Scientific Title
Investigation of the optimum rate of patient controlled epidural analgesia after cesarean section
Scientific Title:Acronym
Investigation of the optimum rate of patient controlled epidural analgesia after cesarean section
Region
| Japan |
Condition
Condition
Cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the optimum rate of patient controlled epidural analgesia after cesarean section
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of postcesarean analgesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
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
Rate of the patient controlled epidural analgesia ; 2ml/h
Interventions/Control_2
Rate of the patient controlled epidural analgesia ; 4ml/h
Interventions/Control_3
Rate of the patient controlled epidural analgesia ; 6ml/h
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Parturients : age 20 to 50 and ASA physical status I and II
Key exclusion criteria
Ptient refusal; known fetal anomalies; contraindication for combined spinal-epidural anesthesia because of hemodynamic, infectious, hemostatic, or neurological problems; severe preeclampsia; contraindication for the drugs used in the protocol; or failure of combined spinal-epidural anesthesia
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | IKUOMI |
| Middle name | |
| Last name | MIKUNI |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
2-1-1-1 Midorogaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2583
mikuni-ikuomi@kbd.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | IKUOMI |
| Middle name | |
| Last name | MIKUNI |
Organization
Asahikawa Medical University
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
078-8510
Address
2-1-1-1 Midorogaoka Higashi, Asahikawa, Hokkaido, JAPAN
TEL
0166-68-2583
Homepage URL
mikuni-ikuomi@kbd.biglobe.ne.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
Funding Source
Organization
Asahikawa Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Asahikawa Medical University
Address
2-1-1-1 Midorogaoka Higashi, Asahikawa, Hokkaido, JAPAN
Tel
0166-68-2583
mikuni-ikuomi@kbd.biglobe.ne.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
| 2013 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000011643
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000011643
Number of participants that the trial has enrolled
27
Results
The study has been terminated due to lack of participant.
Results date posted
| 2020 | Year | 04 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Parturients : age 20 to 50 and ASA physical status I and II
Participant flow
Parturients were divided into 3 groups and administered continuous epidural infusion of 0.2% ropivacaine 2ml/h, 4ml/h or 6ml/h.
Adverse events
None
Outcome measures
Degree of postcesarean analgesia
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2013 | Year | 02 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | 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
| 2013 | Year | 02 | Month | 03 | Day |
Last modified on
| 2020 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011643
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
