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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000011212
Receipt No. 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

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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
Obsterics 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
Email 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
Email mokiyo@ks.kyorin-u.ac.jp

Sponsor
Institute Department of anesthesiology, Kyorin university, School of medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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