UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019794 |
|---|---|
| Receipt number | R000022870 |
| Scientific Title | The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section |
| Date of disclosure of the study information | 2015/11/16 |
| Last modified on | 2018/11/19 04:48:52 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section
Acronym
The efficacy of scheduled IV-Acetaminohen in postcesarean analgesia
Scientific Title
The efficacy of scheduled intravenous Acetaminophen in postoperative analgesia after elective cesarean section
Scientific Title:Acronym
The efficacy of scheduled IV-Acetaminohen in postcesarean analgesia
Region
| Japan |
Condition
Condition
Pain after cesarean section
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy of scheduled IV-Acetaminohen in postcesarean analgesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Time to first need for addistional analgesics
Key secondary outcomes
The frequency ofthe use of additional analgesics for 24h after cesarean section
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
The patients undergone the elective cesarean section under spinal anesthesia
Key exclusion criteria
The patients needed to convert to general anesthesia and remained intubated after the ceaserean section; The patients who requied ICU management
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Serabi Tanabe |
Organization
Tokyo Metropolitan Tama Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-8-29 Musashudai,Fuchu-City, Tokyo,JAPAN
TEL
0423235111
serabi123@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Serabi Tanabe |
Organization
Tokyo Metropolitian Tama Medical Center
Division name
Department of Anesthesiology
Zip code
Address
2-8-29 Musashudai,Fuchu-City, Tokyo,JAPAN
TEL
0423235111
Homepage URL
serabi123@hotmail.com
Sponsor or person
Institute
Tokyo Metropolitan Tama Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
| 2015 | Year | 11 | Month | 16 | 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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 07 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We compare the analgesia after elective cesarean section between before and after the scheduled IV-Acetaminophen protocol implementation.
Management information
Registered date
| 2015 | Year | 11 | Month | 16 | Day |
Last modified on
| 2018 | Year | 11 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022870
