UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035129 |
|---|---|
| Receipt number | R000040042 |
| Scientific Title | continuous wound infiltration on patients undergoing caesarean section |
| Date of disclosure of the study information | 2018/12/05 |
| Last modified on | 2018/12/04 14:08:24 |
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Basic information
Public title
continuous wound infiltration on patients undergoing caesarean section
Acronym
continuous wound infiltration for caesarean section
Scientific Title
continuous wound infiltration on patients undergoing caesarean section
Scientific Title:Acronym
continuous wound infiltration for caesarean section
Region
| Japan |
Condition
Condition
after caesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate which CWI with local anesthetic with intravenous fentanyl administration reduce the side effect of fentanyl or not
To investigate the best method of CWI
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
VAS 2/4/18/22 hours after operation
Key secondary outcomes
the use of intravenous fentanyl
side effect of fentanyl
recovery after operation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
2days
not insert CWI catheter
Interventions/Control_2
2days
insert CWI catheter (on peritoneum)
infiltrate local anesthesia into abdominal wall
Interventions/Control_3
2days
insert CWI catheter (under fascia)
infiltrate local anesthesia into abdominal wall
Interventions/Control_4
2days
insert CWI catheter (on peritoneum)
not infiltrate local anesthesia into abdominal wall
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
Japanese undergoing elective caesarean section
Pfannensteil method
Key exclusion criteria
mental disorder
communication disorder
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiromi Araki |
Organization
Suzuki Hospital
Division name
Anesthesiology Obstetrics and Gynecology
Zip code
Address
1-10-8. Tsukimi-cho, Toyota, Aichi, Japan
TEL
0565-33-8051
hiropan@dg7.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiromi Araki |
Organization
Suzuki Hospital
Division name
Anesthesiology Obstetrics and Gynecology
Zip code
Address
1-10-8. Tsukimi-cho, Toyota, Aichi, Japan
TEL
0565-33-8051
Homepage URL
hiropan@dg7.so-net.ne.jp
Sponsor or person
Institute
Suzuki hospital
Obstetrics and Gynecology
Institute
Department
Personal name
Funding Source
Organization
self finding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
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
| 2018 | Year | 12 | Month | 05 | 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
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 12 | Month | 10 | 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
| 2018 | Year | 12 | Month | 04 | Day |
Last modified on
| 2018 | Year | 12 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040042
