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 2019/06/22 10:57:39

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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

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 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


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

Value
https://center6.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