UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008830 |
|---|---|
| Receipt number | R000010371 |
| Scientific Title | Effects of levobupivacaine containing low molecular weight dextran on transversus abdominis plane block and rectus sheath block |
| Date of disclosure of the study information | 2012/09/01 |
| Last modified on | 2016/06/01 21:52:42 |
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Basic information
Public title
Effects of levobupivacaine containing low molecular weight dextran on transversus abdominis plane block and rectus sheath block
Acronym
Effect of LMWD addition on local anesthetics activity
Scientific Title
Effects of levobupivacaine containing low molecular weight dextran on transversus abdominis plane block and rectus sheath block
Scientific Title:Acronym
Effect of LMWD addition on local anesthetics activity
Region
| Japan |
Condition
Condition
abdominal diseases receiving laparoscopic surgery
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is investigation of the effect of additiono of low molecular weight dextran to local anesthetics in patients receiving transversus abdominis plane block and rectus sheath block.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postoperative pain
plasma concentration of levobupivacaine
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
TAP block and RSB with levobupivacaine diluted by saline are performed just before start of operation.
Interventions/Control_2
TAP block and RSB with levobupivacaine diluted by low molecular weight dextran are performed just before start of operation.
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
patients receiving laparoscopic abdominal surgery
Key exclusion criteria
patients with emergency surgery
patients under unconscious state
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Tsuchiya |
Organization
Osaka City University Medical School
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asah-machi, Abeno-ku, Osaka, Japan
TEL
06-6645-2186
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiko Tsuchiya |
Organization
Osaka CIty University Medical School
Division name
Department of Anesthesiology
Zip code
Address
1-5-7 Asah-machi, Abeno-ku, Osaka, Japan
TEL
Homepage URL
Sponsor or person
Institute
Osaka City University Medical School
Department of Anesthesiology
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
| 2012 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2012 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 08 | Month | 31 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010371
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
