UMIN-CTR Clinical Trial

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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