UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017970 |
|---|---|
| Receipt number | R000020817 |
| Scientific Title | Does Oxytocin facilitate recovery of cesarean section-induced post-operative pain?: an examination of analgesic effects of oxytocin on post-operative pain. |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2020/01/09 12:30:32 |
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Basic information
Public title
Does Oxytocin facilitate recovery of cesarean section-induced post-operative pain?: an examination of analgesic effects of oxytocin on post-operative pain.
Acronym
An examination of analgesic effects of oxytocin on cesarean section-induced post-operative pain.
Scientific Title
Does Oxytocin facilitate recovery of cesarean section-induced post-operative pain?: an examination of analgesic effects of oxytocin on post-operative pain.
Scientific Title:Acronym
An examination of analgesic effects of oxytocin on cesarean section-induced post-operative pain.
Region
| Japan |
Condition
Condition
Parturient women who are going to have cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. To examine whether it is different between cesarean section-induced post-operative pain for parturient women and laparotomy-induced post-operative pain for non parturient women.
2. To examine whether plasma concentrations of oxytocin have relevance to recovery of cesarean section-induced post-operative pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Reductions of movement-evoked pain at 1, 3 and 5 days after the operation.
Key secondary outcomes
Reductions of ongoing pain, area of secondary hyperalgesia and analgesics used in post-operative periods at 1, 3 and 5 days after the operation.
Increases in pain threshold of wounds at 1, 3 and 5 days after the operations.
Correlations between the number of lactation or plasma concentrations of oxytocin and the pain indicators.
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
| 55 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Parturient women who are going to have elective cesarean sections for a single fetus.
2. Non parturient women who are going to have elective simple total abdominal hysterectomy including it together with adnexectomy or enucleatic myomectomy.
Key exclusion criteria
1. Parturient women who had emergency cesarean sections.
2. Parturient women with multiple fetus.
3. Parturient women who are going to have cesarean sections by general aneshtesia.
4. Patients who chronically receive NSAIDs or opioids in pre-operative periods.
5.Patients with peripheral neuropathy.
6.Patients with cognitive impairment and from other countries.
Target sample size
96
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Fuseya |
Organization
Shinshu university hospital
Division name
Anesthesiology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto City, Nagano 390-8621, Japan
TEL
0263-37-2670
sfuseya@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Fuseya |
Organization
Shinshu university hospital
Division name
Anesthesiology
Zip code
3908621
Address
3-1-1 Asahi, Matsumoto City, Nagano 390-8621, Japan
TEL
0263-37-2670
Homepage URL
sfuseya@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
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Ethics Committee of Shinshu University School of Medicine
Address
3-1-1 Asahi, Matsumoto City, Nagano 390-8621, 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
信州大学医学部附属病院（長野県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 19 | 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
13
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
Terminated
Date of protocol fixation
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1.Factors to which we examine relevance: between plasma concentrations of oxytocin or the number of lactation and movement-evoked pain, ongoing pain, pain threshold at the wound, area of secondary hyperalgesia and analgesics used in post-operative periods.
2.prospective observational study
3.We randomly sumple the patients who correspond to eligibility.
Management information
Registered date
| 2015 | Year | 06 | Month | 18 | Day |
Last modified on
| 2020 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020817
