UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027088 |
|---|---|
| Receipt number | R000031049 |
| Scientific Title | Single-blind randomized controlled trial for postoperative analgesic effect of repeated intravenous administration acetaminophen after laparoscopic cholecystectomy. |
| Date of disclosure of the study information | 2017/04/28 |
| Last modified on | 2018/10/22 11:26:11 |
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Basic information
Public title
Single-blind randomized controlled trial for postoperative analgesic effect of repeated intravenous administration acetaminophen after laparoscopic cholecystectomy.
Acronym
Randomized controlled trial for postoperative analgesic effect of acetaminophen after laparoscopic cholecystectomy
Scientific Title
Single-blind randomized controlled trial for postoperative analgesic effect of repeated intravenous administration acetaminophen after laparoscopic cholecystectomy.
Scientific Title:Acronym
Randomized controlled trial for postoperative analgesic effect of acetaminophen after laparoscopic cholecystectomy
Region
| Japan |
Condition
Condition
gallbladder disease
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this research is to evaluate effectiveness of postoperative repeated intravenous administration of acetaminophen for pain and PONV after laparoscopic cholecystectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
dose of additional analgesics
Key secondary outcomes
evaluation with VAS for pain and nausea
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
repeated acetaminophen group
intravenous
1000mg, 24hours, every 6 hours
Interventions/Control_2
single acetaminophen group
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who have an electively operation of laparoscopic cholecystectomy for the benign gallbladder disease and who agree to this study
Key exclusion criteria
none
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujii |
Organization
Ehime Prefectural Central Hospital
Division name
Department of gastroenterological surgery
Zip code
Address
83 Kasuga-cho, Matsuyama City, Ehime, Japan
TEL
0899471111
f1masahiko@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Fujii |
Organization
Ehime Prefectural Central Hospital
Division name
Department of gastroenterological surgery
Zip code
Address
83 Kasuga-cho, Matsuyama City, Ehime, Japan
TEL
0899471111
Homepage URL
f1masahiko@gmail.com
Sponsor or person
Institute
Ehime Prefectural Central 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
| 2017 | Year | 04 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.c-linkage.co.jp/jshbps30/jp/
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
| 2017 | Year | 04 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | Month | 28 | Day |
Last follow-up date
| 2018 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 21 | Day |
Last modified on
| 2018 | Year | 10 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031049
