UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014304 |
|---|---|
| Receipt number | R000015411 |
| Scientific Title | The analgesic effect of regular administration of non steroidal anti-infammatry drags in a cesarean section |
| Date of disclosure of the study information | 2014/06/18 |
| Last modified on | 2025/06/09 22:18:04 |
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Basic information
Public title
The analgesic effect of regular administration of non steroidal anti-infammatry drags in a cesarean section
Acronym
The analgesic effect of regular administration of non steroidal anti-infammatry drags in a cesarean section
Scientific Title
The analgesic effect of regular administration of non steroidal anti-infammatry drags in a cesarean section
Scientific Title:Acronym
The analgesic effect of regular administration of non steroidal anti-infammatry drags in a cesarean section
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
the aim of the study is to investigate the effects of regular administration of non steroidal anti-infammatry drags comparison with epidural anesthesia
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
postoperative pain scores at movement (NRS: numerous rating scale ) in 48hours after spinal anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
epidural anesthesia
Interventions/Control_2
regular administration of non steroidal anti-infammatry drags
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
patients undergoing cesarean section
Key exclusion criteria
contraindications to neuraxial anesthesia
contraindications to any of the medications used in the study
a history of gastrointestinal ulceration
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Misako Takamatsu |
Organization
Niigata University Medical and Dental Hospital
Division name
Operation Department
Zip code
Address
Asahimachidori Niigata Chuo-ku, Niigata
TEL
0252272328
misakotaka@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Misako Takamatsu |
Organization
Niigata University Medical and Dental Hospital
Division name
Operation Department
Zip code
Address
Asahimachidori 1-754 Chuo-ku, Niigata city
TEL
0252272328
Homepage URL
misakotaka@gmail.com
Sponsor or person
Institute
Department of Anesthesiology
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
新潟大学医歯学総合病院（新潟県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 18 | 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
Completed
Date of protocol fixation
| 2014 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 10 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015411
