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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000021706 |
Receipt No. | 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 |
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 |
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Condition | |||
Condition | All patients enrolled in 'Impact on ADL and cognitive function receiving operation' | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients undergoing surgery
patients able to answer questionnaire in Japanese |
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Key exclusion criteria | Patients requiring reoperation | |||
Target sample size | 10000 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Department of Anesthesiology, Nara Medical University |
Institute | |
Department |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024498 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |