UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021706 |
|---|---|
| Receipt number | R000024498 |
| Scientific Title | investigation on an incidence of post surgical persistent pain |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/04/15 15:55:00 |
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Basic information
Public title
investigation on an incidence of post surgical persistent pain
Acronym
investigation on an incidence of post surgical persistent pain
Scientific Title
investigation on an incidence of post surgical persistent pain
Scientific Title:Acronym
investigation on an incidence of post surgical persistent pain
Region
| Japan | Australia |
Condition
Condition
All patients enrolled in 'Impact on ADL and cognitive function receiving operation'
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to investigate the proportion of the postoperative persistent pain and the factors affecting them
Basic objectives2
Others
Basic objectives -Others
Not Applicable
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of postoperative pain
Key secondary outcomes
Variables that affect primary outcome
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
patients will be asked to answer a questionnaire about their postoperative pain and it's nature at 3month and 1year after the surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing surgery
patients able to answer questionnaire in Japanese
Key exclusion criteria
Patients requiring reoperation
Target sample size
10000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kawaguchi Masahiko |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
+81-(0)744-22-3051
drjkawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yusuke Naito |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 Shijo-cho, Kashihara, Nara, Japan
TEL
+81-(0)744-22-3051
Homepage URL
schneider.yusuke@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Self Funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
奈良県立医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 03 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 15 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Patients will be asked if they have persistent postoperative pain 3month after surgery. The patients will be divided into two groups whether they have persistent postoperative pain or not and will be analysed.
Management information
Registered date
| 2016 | Year | 03 | Month | 31 | Day |
Last modified on
| 2016 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024498
