UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000020817