UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010187 |
|---|---|
| Receipt number | 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 10:34:50 |
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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
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
takahiro@nagoya-1st.jrc.or.jp
Sponsor or person
Institute
Japanese Red Cross Nagoya Daiishi Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011894
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
