UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012386 |
|---|---|
| Receipt number | R000014484 |
| Scientific Title | The trial of early administration of pregaablin for post operative thoracotomy pain |
| Date of disclosure of the study information | 2013/11/25 |
| Last modified on | 2016/05/24 18:35:35 |
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Basic information
Public title
The trial of early administration of pregaablin for post operative thoracotomy pain
Acronym
The trial of early administration of pregaablin for post operative thoracotomy pain
Scientific Title
The trial of early administration of pregaablin for post operative thoracotomy pain
Scientific Title:Acronym
The trial of early administration of pregaablin for post operative thoracotomy pain
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
early administration of pregabain to reduce post opearative thoracotomy pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The total amount of additional analgesics in hospital
Key secondary outcomes
1 Numeric rating scale
2 The rate of adverse effect
3 The incidence of post thoracotomy pain
syndrome
4 Pain detect qustionnaire
5 Pain Catastrophizing Scale
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as a block.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
control group
celecoxib 400 mg daily
ropivacaine for epidural ansethesia
Interventions/Control_2
Taking pregabalin on postoperative days to 14 days after operation (150mg/ daily)
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
| 45 | years-old | <= |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
lung cancer patients
PS 0 or 1
Communicatable
Key exclusion criteria
renal dysfunction
intake of some analgesia preoperatively
history of thoracotomy
median sternotomy
Extraplueral pneumonectomy, pleural biopsy, mediastinal tumor
severe complication including, heart,pulmonary,liver and diabetes mellitus and so on
not appropriate for epidural anesthesia
pregnancy
pluerodesis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takeshi Nagayasu |
Organization
Nagasaki University Graduate School of Medicine
Division name
Surgical Oncology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7304
nagayasu@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takuro Miyazaki |
Organization
Nagasaki University Graduate School of Medicine
Division name
Surgical Oncology
Zip code
Address
1-7-1 Sakamoto, Nagasaki
TEL
095-819-7304
Homepage URL
miyataku@nagasaki-u.ac.jp
Sponsor or person
Institute
Surgical Oncology, Nagasaki University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
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 | 11 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially 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
| 2013 | Year | 11 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 11 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 11 | Month | 22 | Day |
Last modified on
| 2016 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014484
| 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 |
