UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial
Title of the study (Brief title)	Effectiveness of postoperative pain control with intravenous acetaminophen (Acelio) following esophageal cancer surgery: A prospective randomize controlled trial
Region	Japan

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

Objectives
Narrative objectives1	To prove positive effect of intravenous acetaminophen in pain control after esophageal cancer surgery added to epidural anesthesia
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Reduce of additional dosage of epidual anesthesia by patient control pump and dosage of NSAIDs as rescue drug.
Key secondary outcomes	Reduce complaint related to opioid,reduce pain, the time of first gait, flatus, constipation,and hospital stay

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	The group with intravenous acetaminofen administration around the clock
Interventions/Control_2	The group without intravenous acetaminofen administration
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	18 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	The patients planed to recieve thoracoscope assisted esophagectomy and hand assisted laparoscopic gastric tube reconstruction and 2 or 3 fields lymphoadenectomy. Maintain major organ function Got an informed consent
Key exclusion criteria	Open thoracotomy or open laparotpmy case One or more wound size over 10 cm in cervial ,thoracic, or abdominal incision. With major organ disfunction.
Target sample size	60

Research contact person
Name of lead principal investigator	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
Email	nishinotakeshi@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 and graduated school
Institute
Department

Funding Source
Organization	Tokushima university and graduated school
Organization
Division
Category of Funding Organization	Other
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	Open public recruiting
Date of protocol fixation	2017 Year 04 Month 01 Day
Anticipated trial start date	2017 Year 04 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry	2019 Year 03 Month 31 Day
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2017 Year 03 Month 03 Day
Last modified on	2017 Year 09 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029913