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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014020
Receipt No. R000016324
Scientific Title prevention study of the postoperative nausea and vomiting by intraoperative intravenous acetaminophen in patients during cesarean section in regional anesthesia.
Date of disclosure of the study information 2014/05/21
Last modified on 2014/05/21

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Basic information
Public title prevention study of the postoperative nausea and vomiting by intraoperative intravenous acetaminophen in patients during cesarean section in regional anesthesia.
Acronym IOANVSC-study
Scientific Title prevention study of the postoperative nausea and vomiting by intraoperative intravenous acetaminophen in patients during cesarean section in regional anesthesia.
Scientific Title:Acronym IOANVSC-study
Region
Japan

Condition
Condition postoperative state of cesarean section
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Intrathecal opioid for post-cesarean analgesia has been recommended because of its efficacy and possibility to early postoperative ambulation. Morphine, water-soluble strong opioid, provides extended analgesia after intrathecal administration and is used in many clinical situations. However, intrathecal morphine causes postoperative nausea and vomiting make sometimes the post cesarean patients' mothering difficult. On the other hand, the efficacy of intraoperative acetaminophen for reducing postoperative nausea and vomiting after general surgery has been reported.
The purpose of this study is to elucidate the efficacy of intraoperative acetaminophen for reducing post-cesarean complications administrated morphine intrathecally.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Incidence of postoperative nausea and vomiting
Key secondary outcomes Change for postoperative pain control

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 acetaminophen
Interventions/Control_2 saline
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
16 years-old <=
Age-upper limit
50 years-old >=
Gender Female
Key inclusion criteria 1.Parturients who will receive cesarean section
2.Performed spinal anesthesia and administered morphine intrathecally
3.
Parturients must have oral communication ability; can provide written informed consent signed by herself under her free will after receiving full explanation of the study
Key exclusion criteria 1.Impaired liver function
2.cesarean section in generaal anesthesia
3.Parturients who do not consent to the nature of the study
Target sample size 180

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Katsuo Terui
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Obstetric Anesthesia, Department of Anesthesiology
Zip code
Address 1981, Kamoda, Kawagoeshi, Saitama,
TEL 049-228-3654
Email suga4423@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshifumi Suga
Organization Saitama Medical Center, Saitama Medical University
Division name Division of Obstetric Anesthesia, Department of Anesthesiology
Zip code
Address 1981, Kamoda, Kawagoeshi, Saitama,
TEL 049-228-3654
Homepage URL
Email suga4423@hotmail.com

Sponsor
Institute Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization Saitama Medical Center, Saitama Medical University
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2014 Year 05 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

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 Preinitiation
Date of protocol fixation
2014 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 21 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 05 Month 21 Day
Last modified on
2014 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016324

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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