UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section
Title of the study (Brief title)	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	Serabi Tanabe
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Department of Anesthesiology
Address	2-8-29 Musashudai,Fuchu-City, Tokyo,JAPAN
TEL	0423235111
Email	serabi123@hotmail.com

Public contact
Name of contact person	Serabi Tanabe
Organization	Tokyo Metropolitian Tama Medical Center
Division name	Department of Anesthesiology
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 07 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000022870