UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000019314
Receipt number R000022330
Scientific Title A comparative investigation about analgesic effect after laparoscopic surgery for patients with gynecologic disease~posterior TAP block vs lateral TAP block
Date of disclosure of the study information 2015/10/12
Last modified on 2015/12/01 06:46:01

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Basic information

Public title

A comparative investigation about analgesic effect after laparoscopic surgery for patients with gynecologic disease~posterior TAP block vs lateral TAP block

Acronym

A comparative investigation about analgesic effect after laparoscopic surgery for patients with gynecologic disease

Scientific Title

A comparative investigation about analgesic effect after laparoscopic surgery for patients with gynecologic disease~posterior TAP block vs lateral TAP block

Scientific Title:Acronym

A comparative investigation about analgesic effect after laparoscopic surgery for patients with gynecologic disease

Region

Japan


Condition

Condition

Gynecological Laparoscopic Operation

Classification by specialty

Obstetrics and Gynecology Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

A comparative investigation about analgesic effect between posterior TAP block and lateral TAP block

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

analgesia scores in perioperative period(visceral pain,somatic pain)

Key secondary outcomes

The total amount of additional analgesics in perioperative period


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


Interventions/Control_2


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

gynecologic surgery with laparoscopic

Key exclusion criteria

except gynecologic surgery with laparoscopic

Target sample size



Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hironobu Ueshima

Organization

Showa university hospital

Division name

Anesthesiology

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

03-3784-8875

Email

ueshimhi@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hironobu Ueshima

Organization

Showa university hospital

Division name

Anesthesiology

Zip code


Address

1-5-8, Hatanodai, Shinagawa-ku, Tokyo, Japan

TEL

03-3784-8875

Homepage URL


Email

ueshimhi@yahoo.co.jp


Sponsor or person

Institute

Showa university hospital

Institute

Department

Personal name



Funding Source

Organization

Showa 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

2015 Year 10 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

Completed

Date of protocol fixation

2015 Year 10 Month 12 Day

Date of IRB


Anticipated trial start date

2015 Year 10 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

Medical record check(the patients between April and September in 2015)
The total amount of additional analgesics in perioperative period
analgesia scores in perioperative period(visceral pain,somatic pain)


Management information

Registered date

2015 Year 10 Month 11 Day

Last modified on

2015 Year 12 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022330


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name