UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022327 |
|---|---|
| Receipt number | R000025722 |
| Scientific Title | Effect of perioperative administration of a duloxetine on development of persistent postsurgical pain |
| Date of disclosure of the study information | 2016/05/16 |
| Last modified on | 2022/11/22 14:20:30 |
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Basic information
Public title
Effect of perioperative administration of a duloxetine on development of persistent postsurgical pain
Acronym
Duloxetine on persistent postsurgical pain
Scientific Title
Effect of perioperative administration of a duloxetine on development of persistent postsurgical pain
Scientific Title:Acronym
Duloxetine on persistent postsurgical pain
Region
| Japan |
Condition
Condition
Patients scheduled to undergo breast, thracic, orthopedic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine whether perioperative administration of duloxetine influences the development of persistent postsurgical pain.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of persistent postsurgical pain at 3 months after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Patients receive duloxetine 20 mg orally, 2 h before surgery, 20 mg once daily for the first 6 postoperative days.
Interventions/Control_2
Patients receive placebo orally, 2 h before surgery, once daily for the first 6 postoperative days.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo breast, thoracic, orthopedic surgery.
Key exclusion criteria
Patients who have a pain around surgical site before surgery.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Yoshiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-0802
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
yoshiyama@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Yoshiyama |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-0802
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
TEL
0263-37-2670
Homepage URL
yoshiyama@shinshu-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine Medical Ethics Committee
Address
3-1-1 Asahi, Matsumoto, Nagano, Japan
Tel
0263-37-2572
mdrinri@shinshu-u.ac.jp
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
| 2016 | Year | 05 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 05 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 10 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025722
