UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021846 |
|---|---|
| Receipt number | R000025189 |
| Scientific Title | The analgesic efficacy of scheduled intravenous acetaminophen in combination with fentanyl intravenous patient controlled analgesia after cesarean section |
| Date of disclosure of the study information | 2016/04/20 |
| Last modified on | 2017/04/09 14:00:05 |
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Basic information
Public title
The analgesic efficacy of scheduled intravenous acetaminophen in combination with fentanyl intravenous patient controlled analgesia after cesarean section
Acronym
Efficacy of acetaminophen in combination with fentanyl IVPCA after cesarean section
Scientific Title
The analgesic efficacy of scheduled intravenous acetaminophen in combination with fentanyl intravenous patient controlled analgesia after cesarean section
Scientific Title:Acronym
Efficacy of acetaminophen in combination with fentanyl IVPCA after cesarean section
Region
| Japan |
Condition
Condition
women schedulled for cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the analgesic efficacy of scheduled intravenous acetaminophen in combination with fentanyl intravenous patient controlled analgesia after cesarean section
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Visual analogue scale at rest and during motion at 0,1,3,6,12 hour after surgery
Key secondary outcomes
The frequency of additional analgesics,
The time to first need for additional analgesics,
Adverse effects
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
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 1g DIV 3 times per day
1day
Interventions/Control_2
normalsaline 100ml DIV 3 times per day
1day
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
ASA 1-2 patients undergoing elective
Cesarean section under spinal anesthesia
Key exclusion criteria
Emergency cases,
Patients with coagulation disorder and liver dysfunction
ASA>3
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keiko Shimohata |
Organization
Kameda Daiichi hospital
Division name
Department of Anesthesiology
Zip code
Address
2-5-22 Nishimachi,Kounanku,Niigata,Niigata
TEL
025-382-3111
migraine12jp@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keiko Shimohata |
Organization
Kameda Daiichi hospital
Division name
Department of Anesthesiology
Zip code
Address
2-5-22 Nishimachi,Kounanku,Niigata,Niigata
TEL
025-382-3111
Homepage URL
migraine12jp@gmail.com
Sponsor or person
Institute
Sato hospital,department of obstetrics and gynecology
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
産科婦人科舘出張佐藤病院(群馬県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 20 | 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
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
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2016 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 20 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 20 | Day |
Date analysis concluded
| 2016 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 09 | Day |
Last modified on
| 2017 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025189
