UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003598 |
|---|---|
| Receipt number | R000004364 |
| Scientific Title | The analgesic efficacy and safety of transversus abdominis plane (TAP) block with levobupivacaine in abdominal surgery under general anesthesia |
| Date of disclosure of the study information | 2010/06/21 |
| Last modified on | 2015/11/11 15:05:00 |
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Basic information
Public title
The analgesic efficacy and safety of transversus abdominis plane (TAP) block with levobupivacaine in abdominal surgery under general anesthesia
Acronym
The analgesic efficacy and safety of transversus abdominis plane (TAP) block with levobupivacaine
Scientific Title
The analgesic efficacy and safety of transversus abdominis plane (TAP) block with levobupivacaine in abdominal surgery under general anesthesia
Scientific Title:Acronym
The analgesic efficacy and safety of transversus abdominis plane (TAP) block with levobupivacaine
Region
| Japan |
Condition
Condition
Abdominal diseases
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the safety and analgesic efficacy of transversus abdominis plane block with levobupivacaine
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We measure blood concentrations of levobupivacaine for evaluating the safety.
Key secondary outcomes
We record the pain score (visual analog scale) and postoperative analgesic requirements for evaluating the analgesic efficacy of TAP block with levobupivacaine
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
The TAP blocks with levobupivacaine are performed to the patients scheduled for abdominal surgery under general anesthesia.
Interventions/Control_2
The TAP blocks with levobupivacaine are not performed.
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
ASA Physical status I-III patients scheduled for abdominal surgery under general anesthesia
Key exclusion criteria
Severe renal and liver dysfunction
A history of relevant drug allergy
Medical therapies considered to result in tolerance to opiates
Epidural anesthesia
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanaka |
Organization
Shinshu University school of medicine
Division name
Dept. Anesthesiology and Resuscitology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano 390-8621 Japan
TEL
0263-37-2760
s_tanaka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Tanaka |
Organization
Shinshu University school of medicine
Division name
Dept. Anesthesiology and Resuscitology
Zip code
Address
3-1-1 Asahi, Matsumoto, Nagano
TEL
0263-37-2670
Homepage URL
s_tanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Dept. Anesthesiology and Resuscitology, Shinshu University school of Medicine
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
信州大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 21 | 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
| 2010 | Year | 06 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | 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
| 2010 | Year | 05 | Month | 11 | Day |
Last modified on
| 2015 | Year | 11 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004364
