UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Title of the study (Brief title)	Comparison of post-operative analgesia for gynecologic abdominal operation by transverse abdominal plain (TAP)block with or without buprenorphine
Region	Japan

Condition
Condition	uterine myoma
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the post-operative analgesia for gynecologic abdominal surgery by transverse abdominal plain (TAP) block with or without buprenorphine
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate the difference of pain and nausea scale by TAP block with or without buprenorphine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Without buprenorphine
Interventions/Control_2	Local anesthetics and buprenorphine
Interventions/Control_3	buprenorphine im
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Gynecological abdominal surgery
Key exclusion criteria	Medicated painkiller
Target sample size	60

Research contact person
Name of lead principal investigator	Makiko Komori
Organization	Tokyo Women's Medical University
Division name	Anesthesiology
Address	2-1-10 Nishiogu Arakawaku Tokyo
TEL	03-3810-1111
Email	mkomori@ocn.ne.jp

Public contact
Name of contact person	Mitsuharu Kodaka
Organization	Tokyo Women's Medical University
Division name	Anesthesiology
Address	2-1-10 Nishiogu Arakawaku Tokyo
TEL	03-3810-1111
Homepage URL
Email	kmkodaka@cb3.so-net.ne.jp

Sponsor
Institute	Tokyo Women's Medical University
Institute
Department

Funding Source
Organization	Tokyo Women's Medical University
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	2015 Year 03 Month 17 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2014 Year 04 Month 01 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	2015 Year 03 Month 17 Day
Last modified on	2017 Year 09 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000015072