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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017970
Receipt No. 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

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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
Email 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
Email sfuseya@shinshu-u.ac.jp

Sponsor
Institute Department of Anesthesiology and Resuscitology, Shinshu University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020817

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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