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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003598
Receipt No. 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

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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 Obsterics 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
Email 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
Email s_tanaka@shinshu-u.ac.jp

Sponsor
Institute Dept. Anesthesiology and Resuscitology, Shinshu University school of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004364

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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