UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study.
Title of the study (Brief title)	The effect of intravenous acetaminophen on postoperative pain control after esophageal cancer surgery, a prospective randomized study.
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To prove the efficacy of intravenous acetamonophen on postoperative pain control after esophageal cancer surgery compared with epidural anesthesia alone.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Phase III

Assessment
Primary outcomes	The frequency of analgesic rescue dose
Key secondary outcomes	Side effect of opioid Pain(until 7 days after surgery) The days until first gait, flatus, and constipation after surgery Hospital stay days after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
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	Using asetaminophen until 7days after surgery. 4 times per a day, 15mg/kg Combination with epidural anesthesia
Interventions/Control_2	Not using asetaminophen. Only epidural anesthesia
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	90 years-old >=
Gender	Male and Female
Key inclusion criteria	a person older than 20 years old sex dose not matter a person who was informed sufficiently, and agree to participate this study of one's free will
Key exclusion criteria	A person who had contraindication about treatment below, 1,Epidural analgesia 2,using acetaminophen 3,using NSAIDs A person who do not agree to participate this study and was unsuitable for this study
Target sample size	60

Research contact person
Name of lead principal investigator	Akira Tangoku
Organization	Tokushima university and graduated school,
Division name	Thoracic, endocrine oncology and surgery
Address	18-15, Kuramotocho,Tokushima,Japan
TEL	088-633-7173
Email	tangoku@tokushima-u.ac.jp

Public contact
Name of contact person	Takeshi Nishino
Organization	Tokushima university and graduated school
Division name	Thoracic, endocrine oncology and surgery
Address	18-15, Kuramotocho,Tokushima,Japan
TEL	088-633-7173
Homepage URL
Email	nishinotakeshi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima university
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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 31 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 17 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete	2019 Year 03 Month 31 Day
Date analysis concluded	2019 Year 03 Month 31 Day

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

Management information
Registered date	2017 Year 02 Month 21 Day
Last modified on	2019 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030100