UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000014304
Receipt No. 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 2019/06/22

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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
Email 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
Email misakotaka@gmail.com

Sponsor
Institute Department of Anesthesiology
Niigata University Medical and Dental Hospital
Institute
Department

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
Email

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 Open public recruiting
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
2019 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015411

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.