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

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 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


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

Value
https://center6.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