UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010339
Receipt number R000012103
Scientific Title Analgesic effect and blood concentration of paravertebral block in pneumectomy
Date of disclosure of the study information 2013/03/29
Last modified on 2015/03/30 09:07:33

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Basic information

Public title

Analgesic effect and blood concentration of paravertebral block in pneumectomy

Acronym

Analgesic effect and blood concentration of paravertebral block in pneumectomy

Scientific Title

Analgesic effect and blood concentration of paravertebral block in pneumectomy

Scientific Title:Acronym

Analgesic effect and blood concentration of paravertebral block in pneumectomy

Region

Japan


Condition

Condition

Case to undergo operation of lobectomy and lymphadenectomy with standerd thoracotomy

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We compare the analgesic effect in paravertebral block after operation

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

drug blood concentration

Key secondary outcomes

visual analog scale, blood pressure, pulse rate, SpO2, breathing number of times, complications, side effect, difference of kind and use frequency of the additional analgesic agent, length of stay


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

parabertebral block group

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

15 years-old <=

Age-upper limit

80 years-old >=

Gender

Male and Female

Key inclusion criteria

ASA PS one or two
age from twenty toseventy five years olds
male and female
The patient that a document agreement by the free will of a patient was provided

Key exclusion criteria

don't get agreement
ASA, more than three
interstitial pneumonia
pulmonary fibrosis
severe asthma
pulmonary emphysema
central nervous system disorder and peripheral nerve disorder
coagulation disorder
thrombocytopenia
doing anticoagulation therapy
sepsis
infection of puncuture skin
severe heart disease
cirrhosis
renal failure
severe diabetes mellitus
anemia
allergy of local anesthesis
maternal
past history of same side thoracotomy
risl of pleural adhesion
pasy history of radiotherapy
difficult anesthesia which was set of the Minister of Health, Labour and Welfare
and, the patients who was judged that a trial entry was inappropriate

Target sample size

15


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Tamura

Organization

Japanese Red Cross Nagoya Daiichi Hospital

Division name

Department of Anesthesia

Zip code


Address

Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan

TEL

052-481-1111

Email

takahiro@nagoya-1st.jrc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name takahiro tamura

Organization

Japanese Red Cross Nagoya Daiichi Hospital

Division name

Department of Anesthesia

Zip code


Address

ichishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan

TEL

052-481-1111

Homepage URL


Email

takahiro@nagoya-1st.jrc.or.jp


Sponsor or person

Institute

Japanese Red Cross Nagoya Daiichi Hospital

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesia, Nagoya University Graduate School of medicine, Aichi, Japan

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

2013 Year 03 Month 29 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

2012 Year 12 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 12 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2014 Year 12 Month 31 Day

Date trial data considered complete

2015 Year 03 Month 31 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 28 Day

Last modified on

2015 Year 03 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012103


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name