UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014487 |
|---|---|
| Receipt number | 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 08:27:47 |
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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
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
mgo@tokushima-med.jrc.or.jp
Sponsor or person
Institute
Tokushima Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016853
