UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018024 |
|---|---|
| Receipt number | R000012277 |
| Scientific Title | Plasma levobipivacaine concentration after abdominal block |
| Date of disclosure of the study information | 2015/06/22 |
| Last modified on | 2015/10/07 14:44:05 |
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Basic information
Public title
Plasma levobipivacaine concentration after abdominal block
Acronym
Plasma levobipivacaine concentration after abdominal block
Scientific Title
Plasma levobipivacaine concentration after abdominal block
Scientific Title:Acronym
Plasma levobipivacaine concentration after abdominal block
Region
| Japan |
Condition
Condition
colon carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Measurementof plasma levobupivacaine after abdominal block
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
plasma concentration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
over 20 years old and scheduled for mid-line incision surgery of laparoscopic colectomy were recruited at Gunma University Hospital.
Key exclusion criteria
1)patient who did not have the block
2)patient who had an allergy to local anesthetics
3)patient who refused to join the study
4)patient who was judged as inadequite
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nakajima Kunie |
Organization
Gunma University Hospital
Division name
Anesthesiology
Zip code
Address
3-39-15 Showa, Maebashi, Gunma, Japan
TEL
027-220-8454
knkunie@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nakajima |
Organization
Gunma University Hospital
Division name
Anesthesiology
Zip code
Address
3-39-15 Shouwa, Mebashi, Gunma, Japan
TEL
0272208454
Homepage URL
knkunie@yahoo.co.jp
Sponsor or person
Institute
Gunma Univresity Hospital
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2015 | Year | 06 | Month | 22 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
the use of 150mg of levobupivacaine for RSB and TAPB before the operations seems almost safety as long as watching carefully at least 45 minutes after the blocks for mid-line incision surgery of laparoscopic colectomy.
Management information
Registered date
| 2015 | Year | 06 | Month | 22 | Day |
Last modified on
| 2015 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012277
