UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013931
Receipt number R000016243
Scientific Title comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology
Date of disclosure of the study information 2014/05/12
Last modified on 2017/05/16 14:01:33

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Basic information

Public title

comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology

Acronym

comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology

Scientific Title

comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology

Scientific Title:Acronym

comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology

Region

Japan


Condition

Condition

laparoscopic surgery in gynecology

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

comparison of pain, blood concentration of local analgesia, heart rate variability and side effect after laparoscopic surgery in gynecology between anterior tap block and posterior tap block

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pain

Key secondary outcomes

blood concentration of local analgesia
heart rate variability analysis
complication


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -but assessor(s) are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

anterior TAP block

Interventions/Control_2

posterior TAP block

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

Female

Key inclusion criteria

the patient who are going to take laparoscopic surgery at gynecology

Key exclusion criteria

the patient who do not consent with this study
the patient who has dementia to take pain scale
the patient who has allergic to local analgesia
the patient who has allergic to opioid
the patient who judged other chief physicians to be inappropriate about the study concerned

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name kazuo ando

Organization

aichi medical university hospital

Division name

anesthesiology

Zip code


Address

karimata1-1 yazako nagakute aichi

TEL

0561623311

Email

ando_kazuo0210@hotmail.com


Public contact

Name of contact person

1st name
Middle name
Last name kazuo ando

Organization

aichi medical university hospital

Division name

anesthesiology

Zip code


Address

karimata1-1 yazako nagakute aichi

TEL

0561623311

Homepage URL


Email

ando_kazuo0210@hotmail.com


Sponsor or person

Institute

aichi medical university hospital

Institute

Department

Personal name



Funding Source

Organization

aichi medical university hospital

Organization

Division

Category of Funding Organization

Other

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



Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 12 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

Terminated

Date of protocol fixation

2014 Year 05 Month 12 Day

Date of IRB


Anticipated trial start date

2014 Year 05 Month 12 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

2014 Year 05 Month 12 Day

Last modified on

2017 Year 05 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016243


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name