UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046152 |
|---|---|
| Receipt number | R000049789 |
| Scientific Title | Evaluation of chronic pain after cesarean section |
| Date of disclosure of the study information | 2021/11/23 |
| Last modified on | 2023/10/14 09:59:23 |
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Basic information
Public title
Evaluation of chronic pain after cesarean section
Acronym
Evaluation of chronic pain after cesarean section
Scientific Title
Evaluation of chronic pain after cesarean section
Scientific Title:Acronym
Evaluation of chronic pain after cesarean section
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of chronic pain after cesarean section
Basic objectives2
Others
Basic objectives -Others
Evaluation of chronic pain after cesarean section
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence and severity of chronic pain
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
after C/S surgery
Key exclusion criteria
none
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | Tamura |
| Last name | Tamura |
Organization
Nagoya Unniversity
Division name
Anesthesiology
Zip code
466-8550
Address
Nagoya
TEL
0527412111
takahiro@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | Tamura |
| Last name | Tamura |
Organization
Nagoya University Graduate School of Medicine
Division name
Anesthesiology
Zip code
466-8550
Address
Nagoya
TEL
0527412111
Homepage URL
takahiro@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Nagoya University Hospital
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine
Address
Showa-ku
Tel
+81527412111
takahiro@med.nagoya-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
| 2021 | Year | 11 | Month | 23 | Day |
Related information
URL releasing protocol
h
Publication of results
Unpublished
Result
URL related to results and publications
h
Number of participants that the trial has enrolled
80
Results
There was no association between acute and chronic pain 6 hours after surgery.
There was no association between operation time and chronic pain or EQ -5 D -5 L.
In this study, 4.4% (4/90) of patients had ongoing chronic pain 5 years after surgery.
Results date posted
| 2022 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
C/S
Participant flow
patients after RCT
Adverse events
non
Outcome measures
　non
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 11 | Month | 23 | Day |
Last modified on
| 2023 | Year | 10 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049789
