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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035129
Receipt No. R000040042
Official scientific title of the study continuous wound infiltration on patients undergoing caesarean section
Date of disclosure of the study information 2018/12/05
Last modified on 2018/12/04

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Basic information
Official scientific title of the study continuous wound infiltration on patients undergoing caesarean section
Title of the study (Brief title) continuous wound infiltration for caesarean section
Region
Japan

Condition
Condition after caesarean section
Classification by specialty
Obsterics 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 Hiromi Araki
Organization Suzuki Hospital
Division name Anesthesiology Obstetrics and Gynecology
Address 1-10-8. Tsukimi-cho, Toyota, Aichi, Japan
TEL 0565-33-8051
Email hiropan@dg7.so-net.ne.jp

Public contact
Name of contact person Hiromi Araki
Organization Suzuki Hospital
Division name Anesthesiology Obstetrics and Gynecology
Address 1-10-8. Tsukimi-cho, Toyota, Aichi, Japan
TEL 0565-33-8051
Homepage URL
Email hiropan@dg7.so-net.ne.jp

Sponsor
Institute Suzuki hospital
Obstetrics and Gynecology
Institute
Department

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

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040042

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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