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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010187
Receipt No. R000011894
Scientific Title Randomized Controlled Trial of Analgesic effect of epidural anesthesia and paravertebral block in pneumectomy
Date of disclosure of the study information 2013/03/07
Last modified on 2017/02/13

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Basic information
Public title Randomized Controlled Trial of Analgesic effect of epidural anesthesia and paravertebral block in pneumectomy
Acronym Analgesic effect of epidural anesthesia and paravertebral block - Randomized Controlled Trial -
Scientific Title Randomized Controlled Trial of Analgesic effect of epidural anesthesia and paravertebral block in pneumectomy
Scientific Title:Acronym Analgesic effect of epidural anesthesia and paravertebral block - Randomized Controlled Trial -
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 between epidural anesthesia and paravertebral block after operation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes visual analog scale
Key secondary outcomes drug blood concentration, 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
Evaluation of postoperative chronic pain

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 epidural anethesia group
Interventions/Control_2 parabertebral block group
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 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 80

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 0524815111
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 Michishita-cho, nakamura-ku, Nagoya, Aichi 453-8511, Japan
TEL 0524815111
Homepage URL
Email takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute Japanese Red Cross Nagoya Daiishi Hospital
Institute
Department

Funding Source
Organization Department of Anesthesia, Japanese Red Cross Nagoya Daiichi 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
2013 Year 03 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

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 19 Day
Last follow-up date
2015 Year 11 Month 30 Day
Date of closure to data entry
2015 Year 11 Month 30 Day
Date trial data considered complete
Date analysis concluded
2015 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 03 Month 07 Day
Last modified on
2017 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011894

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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