UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination about the usefulness of the acetaminophen for intravenous injections after the operation of laparoscopic groin hernia restoration
Title of the study (Brief title)	Examination about the usefulness of the acetaminophen for intravenous injections after the operation of laparoscopic groin hernia restoration
Region	Japan

Condition
Condition	groin hernia
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	A pain occurs after the laparoscopic groin hernia restoration in a short term. NSAIDs or fentanyl continuous intravenous infusion is used to hang around for the sharp pain by facilities and an anesthesiologist, a surgeon. This time, we attempt to study the usage of the acetaminophen for intravenous injections whether it was useful for painkilling after the laparoscopic groin hernia restoration and it could reduce perioperative opioid consumption.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Dosage of additional pain-killer
Key secondary outcomes	Pain level, time of pain-killer use, the number of the harmful phenomenon (shivering, nausea, vomiting)

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	Control group:Fentanyl sustained intravenous administration (0.3 micro gram/kg/h), given since 30 minutes before operation end.
Interventions/Control_2	Study group:Use the Intravenous acetaminophen since 30 minutes before operation end, and 3 times per 6 hour.Dosage is 15 mg/kg for the patient less than 50 kg in weight and 1000 mg for the patient more than 50 kg in weight.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	All patients who receive a target operation
Key exclusion criteria	A patient who always use a pain-killer, has a liver function disorder(AST or ALT>100), is obesity(BMI >=30), cannot understand the protocol.
Target sample size	100

Research contact person
Name of lead principal investigator	Michihisa Kato
Organization	Tokushima Red Cross Hospital
Division name	Anesthesiology
Address	Komatsushima Irinokuchi 103
TEL	0885-32-2555
Email	mmkato@tokushima-med.jrc.or.jp

Public contact
Name of contact person	Masanori Go
Organization	Tokushima Red Cross Hospital
Division name	Anesthesiology
Address	Komatsushima Irinokuchi 103
TEL	0885-32-2555
Homepage URL
Email	mgo@tokushima-med.jrc.or.jp

Sponsor
Institute	Tokushima Red Cross Hospital
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	2014 Year 07 Month 07 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 07 Day
Anticipated trial start date	2014 Year 07 Month 07 Day
Last follow-up date	2015 Year 08 Month 31 Day
Date of closure to data entry	2016 Year 11 Month 15 Day
Date trial data considered complete	2016 Year 11 Month 15 Day
Date analysis concluded	2016 Year 11 Month 15 Day

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

Management information
Registered date	2014 Year 07 Month 06 Day
Last modified on	2016 Year 12 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016853