UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014020 |
|---|---|
| Receipt number | 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 14:30:16 |
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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
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
suga4423@hotmail.com
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016324
