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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000019794
Receipt No. R000022870
Scientific Title The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section
Date of disclosure of the study information 2015/11/16
Last modified on 2018/11/19

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Basic information
Public title The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section
Acronym The efficacy of scheduled IV-Acetaminohen in postcesarean analgesia
Scientific Title The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section
Scientific Title:Acronym The efficacy of scheduled IV-Acetaminohen in postcesarean analgesia
Region
Japan

Condition
Condition Pain after cesarean section
Classification by specialty
Anesthesiology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate the efficacy of scheduled IV-Acetaminohen in postcesarean analgesia
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Time to first need for addistional analgesics
Key secondary outcomes The frequency ofthe use of additional analgesics for 24h after cesarean section

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria The patients undergone the elective cesarean section under spinal anesthesia
Key exclusion criteria The patients needed to convert to general anesthesia and remained intubated after the ceaserean section; The patients who requied ICU management
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Serabi Tanabe
Organization Tokyo Metropolitan Tama Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-8-29 Musashudai,Fuchu-City, Tokyo,JAPAN
TEL 0423235111
Email serabi123@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Serabi Tanabe
Organization Tokyo Metropolitian Tama Medical Center
Division name Department of Anesthesiology
Zip code
Address 2-8-29 Musashudai,Fuchu-City, Tokyo,JAPAN
TEL 0423235111
Homepage URL
Email serabi123@hotmail.com

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 16 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 No longer recruiting
Date of protocol fixation
2015 Year 07 Month 09 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 09 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information We compare the analgesia after elective cesarean section between before and after the scheduled IV-Acetaminophen protocol implementation.

Management information
Registered date
2015 Year 11 Month 16 Day
Last modified on
2018 Year 11 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022870

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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