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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000039338
Receipt No. R000044582
Scientific Title Prospective comparative study of the analgesic effect of dural puncture epidural for labor analgesia by infusion rate of local anesthetics.
Date of disclosure of the study information 2020/02/15
Last modified on 2020/01/31

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Basic information
Public title Does the difference of the infusion rate local anesthetics in labor analgesia affect the analgesic effect?
Acronym Comparative study of drug injection rates in labor analgesia.
Scientific Title Prospective comparative study of the analgesic effect of dural puncture epidural for labor analgesia by infusion rate of local anesthetics.
Scientific Title:Acronym Comparative study of analgesic effect of dural puncture epidural by difference in infusion rate.
Region
Japan

Condition
Condition Pregnancy
Classification by specialty
Obsterics and gynecology Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In pregnant women who perform painless delivery by dural puncture epidural analgesia, the difference in analgesic effect between the fast group and the slow (equivalent to daily practice) group of local anesthetic administration rate to epidural space, Look at the difference in the frequency of side effects.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time and total anesthetic dose required to eliminate cold sensation to the 10th thoracic cord level
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Group that administers local anesthetic at a rate of 0.4 ml / sec
Interventions/Control_2 Group that administers local anesthetic at a rate of 0.1 ml / sec
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
46 years-old >=
Gender Female
Key inclusion criteria Pregnant women who are scheduled to undergo labor analgesia by dural puncture epidural technique and who have agreed to participate in the study.
Pregnant women with normotensive blood pressure and no proteinuria (qualitative urine 1+) with ASA physical status 1 or 2
Key exclusion criteria Chronic use of any drug, smoking, high blood pressure, diabetes, thyroid disease, nerve palsy, severe fetal malformation, fetal death or complicated heart disease.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name TOSHIYUKI
Middle name
Last name OKUTOMI
Organization Kitasato university
Division name Department of anesthesiology, school of medicine
Zip code 2280375
Address 1-15-1 Kitasato, Minami-Ku Sagamihara City
TEL 042-778-8606
Email tokutomi@kitasato-u.ac.jp

Public contact
Name of contact person
1st name SHUNSUKE
Middle name
Last name HYUGA
Organization Kitasato university
Division name Department of anesthesiology, school of medicine
Zip code 2280375
Address 1-15-1 Kitasato, Minami-Ku Sagamihara City
TEL 042-778-8606
Homepage URL
Email shyuga@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

Funding Source
Organization Sel funding
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 The Kitasato Institute,Clinical Research Review Board
Address 1-15-1 Kitasato, Minami-Ku Sagamihara City
Tel 042-778-8273
Email rinrib@med.kitasato-u.ac.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
2020 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2020 Year 02 Month 15 Day
Date of IRB
Anticipated trial start date
2020 Year 02 Month 15 Day
Last follow-up date
2023 Year 02 Month 15 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 01 Month 31 Day
Last modified on
2020 Year 01 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044582

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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