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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012386
Receipt No. 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

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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
Email 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
Email miyataku@nagasaki-u.ac.jp

Sponsor
Institute Surgical Oncology, Nagasaki University Graduate School of Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014484

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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