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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014487
Receipt No. R000016853
Scientific Title Examination about the usefulness of the acetaminophen for intravenous injections after the operation of laparoscopic groin hernia restoration
Date of disclosure of the study information 2014/07/07
Last modified on 2016/12/28

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Basic information
Public title Examination about the usefulness of the acetaminophen for intravenous injections after the operation of laparoscopic groin hernia restoration
Acronym Examination about the usefulness of the acetaminophen for intravenous injections after the operation of laparoscopic groin hernia restoration
Scientific Title Examination about the usefulness of the acetaminophen for intravenous injections after the operation of laparoscopic groin hernia restoration
Scientific Title:Acronym 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
1st name
Middle name
Last name Michihisa Kato
Organization Tokushima Red Cross Hospital
Division name Anesthesiology
Zip code
Address Komatsushima Irinokuchi 103
TEL 0885-32-2555
Email mmkato@tokushima-med.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masanori Go
Organization Tokushima Red Cross Hospital
Division name Anesthesiology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 07 Month 07 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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