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Name
UMIN ID

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009939
Receipt No. 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

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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
Email 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
Email mikuni-ikuomi@kbd.biglobe.ne.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

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
Email 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
URL(English) 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
Registered date File name

Research case data
Registered date File name


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