UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039338 |
|---|---|
| Receipt number | 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 | 2020/05/13 20:32:16 |
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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
| Obstetrics and Gynecology | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In pregnant women undergoing labor analgesia by epidural puncture epidural technic, the speed of administration of local anesthetic to the epidural space was compared between the fast and slow (equivalent to daily practice) groups to see the difference in analgesic effect and the frequency of side effects.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time to achieve cold dissipation to the 10th thoracic level and total anesthetic dosage
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
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
shyuga@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
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
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 | 05 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044582
| 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 |
