UMIN-CTR Clinical Trial

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