UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The analgesic efficacy of scheduled intravenous acetaminophen in combination with fentanyl intravenous patient controlled analgesia after cesarean section
Title of the study (Brief title)	Efficacy of acetaminophen in combination with fentanyl IVPCA after cesarean section
Region	Japan

Condition
Condition	women schedulled for cesarean section
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the analgesic efficacy of scheduled intravenous acetaminophen in combination with fentanyl intravenous patient controlled analgesia after cesarean section
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Visual analogue scale at rest and during motion at 0,1,3,6,12 hour after surgery
Key secondary outcomes	The frequency of additional analgesics, The time to first need for additional analgesics, Adverse effects

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Acetaminophen 1g DIV 3 times per day 1day
Interventions/Control_2	normalsaline 100ml DIV 3 times per day 1day
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	45 years-old >=
Gender	Female
Key inclusion criteria	ASA 1-2 patients undergoing elective Cesarean section under spinal anesthesia
Key exclusion criteria	Emergency cases, Patients with coagulation disorder and liver dysfunction ASA>3
Target sample size	40

Research contact person
Name of lead principal investigator	Keiko Shimohata
Organization	Kameda Daiichi hospital
Division name	Department of Anesthesiology
Address	2-5-22 Nishimachi,Kounanku,Niigata,Niigata
TEL	025-382-3111
Email	migraine12jp@gmail.com

Public contact
Name of contact person	Keiko Shimohata
Organization	Kameda Daiichi hospital
Division name	Department of Anesthesiology
Address	2-5-22 Nishimachi,Kounanku,Niigata,Niigata
TEL	025-382-3111
Homepage URL
Email	migraine12jp@gmail.com

Sponsor
Institute	Sato hospital,department of obstetrics and gynecology
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	産科婦人科舘出張佐藤病院(群馬県）

Other administrative information
Date of disclosure of the study information	2016 Year 04 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 04 Month 20 Day
Anticipated trial start date	2016 Year 04 Month 20 Day
Last follow-up date	2016 Year 10 Month 20 Day
Date of closure to data entry	2016 Year 11 Month 20 Day
Date trial data considered complete	2016 Year 11 Month 20 Day
Date analysis concluded	2016 Year 12 Month 20 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 04 Month 09 Day
Last modified on	2017 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025189