UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery
Title of the study (Brief title)	Comparison of postoperative pain of rectus sheath block,epidural analgesia in gynaecological cancer surgery
Region	Japan

Condition
Condition	gynaecological cancer
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To compare postoperative pain of rectus sheath block or epidural analgesia in gynaecological cancer surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	NRS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	continuous rectus sheath block
Interventions/Control_2	epidural analgesia
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	80 years-old >=
Gender	Female
Key inclusion criteria	gynecologic malignant tumor
Key exclusion criteria	chronic pain perfomance state>3 disagree consent of patient and its family
Target sample size	200

Research contact person
Name of lead principal investigator	kuniyoshi Hidkei
Organization	Tokyo jikei university of kashiwa hospital
Division name	anesthesiology
Address	chiba kashiwa kashiwashita 163-1
TEL	04-7164-1111
Email	kuniyoshi0621@yahoo.co.jp

Public contact
Name of contact person	Kuniyoshi hideki
Organization	Tokyo jikei university kashiwa of hospital
Division name	anesthesiology
Address	chiba kashiwa kashiwashita 163-1
TEL	04-7164-1111
Homepage URL
Email	kuni92@jikei.ac.jp

Sponsor
Institute	jikei university kashiwa of hospital
Institute
Department

Funding Source
Organization	Tokyo jikei university of kashiwa hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2016 Year 02 Month 29 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 01 Day
Anticipated trial start date	2015 Year 08 Month 01 Day
Last follow-up date	2017 Year 07 Month 01 Day
Date of closure to data entry	2017 Year 08 Month 01 Day
Date trial data considered complete	2017 Year 09 Month 01 Day
Date analysis concluded	2017 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Evalutating of pain and post nausea and vomitting after postoperative of four,six, eight,twelve,twenty-four,thirty-six

Management information
Registered date	2016 Year 02 Month 29 Day
Last modified on	2018 Year 09 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023082