UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of levobupivacaine containing low molecular weight dextran on transversus abdominis plane block and rectus sheath block
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Masahiko Tsuchiya
Organization	Osaka City University Medical School
Division name	Department of Anesthesiology
Address	1-5-7 Asah-machi, Abeno-ku, Osaka, Japan
TEL	06-6645-2186
Email

Public contact
Name of contact person	Masahiko Tsuchiya
Organization	Osaka CIty University Medical School
Division name	Department of Anesthesiology
Address	1-5-7 Asah-machi, Abeno-ku, Osaka, Japan
TEL
Homepage URL
Email

Sponsor
Institute	Osaka City University Medical School Department of Anesthesiology
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000010371