UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011212 |
|---|---|
| Receipt number | R000013141 |
| Scientific Title | Observation of the transition from acute to chronic pain following cesarean section |
| Date of disclosure of the study information | 2013/07/22 |
| Last modified on | 2016/07/18 20:36:32 |
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Basic information
Public title
Observation of the transition from acute to chronic pain following cesarean section
Acronym
The transition from acute to chronic pain following cesarean section
Scientific Title
Observation of the transition from acute to chronic pain following cesarean section
Scientific Title:Acronym
The transition from acute to chronic pain following cesarean section
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
An observational study to evaluate the effect of postoperative pain management on chronic pain following cesarean section
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of the transition from acute to chronic pain following cesarean section
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
| Not applicable |
Gender
Female
Key inclusion criteria
Patients undergoing elective cesarean section at Kyorin university hospital
Key exclusion criteria
under 20 years of age
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kumi Moriyama |
Organization
Kyorin university, School of medicine
Division name
Department of anesthesiology
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611
TEL
0422-47-5511
mokiyo@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kumi Moriyama |
Organization
Kyorin university, School of medicine
Division name
Department of anesthesiology
Zip code
Address
6-20-2 Shinkawa, Mitaka, Tokyo 181-8611
TEL
0422-47-5511
Homepage URL
mokiyo@ks.kyorin-u.ac.jp
Sponsor or person
Institute
Department of anesthesiology, Kyorin university, School of medicine
Institute
Department
Personal name
Funding Source
Organization
Department of anesthesiology, Kyorin university, School of medicine
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
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
杏林大学病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 01 | Day |
Other
Other related information
Among 225 patients who questionnaires, 69 (30.7%) of patients complained of persistent pain, although no patient required pain medication. Multivariate analyses identified lighter weight (p = 0.011) and non-intrathecal administration of morphine (p = 0.023) as determinant factors associated with persistent pain at 3 months. The adjusted odds ratio of intrathecal administration of morphine to reduce persistent pain was 0.424, suggesting that intrathecal administration of morphine could decrease chronic pain by 50%. In addition, 51.6% of patients had abnormal wound sensation, suggesting the development of neuropathic pain. Also, 6% of patients with abnormal wound sensation required medication, yet no patients with persistent pain required medication.
Management information
Registered date
| 2013 | Year | 07 | Month | 17 | Day |
Last modified on
| 2016 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013141
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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