UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology
Title of the study (Brief title)	comparison of anterior TAP block and posterior TAP block after laparoscopic abdominal surgery at gynecology
Region	Japan

Condition
Condition	laparoscopic surgery in gynecology
Classification by specialty	Obsterics and gynecology Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	comparison of pain, blood concentration of local analgesia, heart rate variability and side effect after laparoscopic surgery in gynecology between anterior tap block and posterior tap block
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pain
Key secondary outcomes	blood concentration of local analgesia heart rate variability analysis complication

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	anterior TAP block
Interventions/Control_2	posterior TAP block
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	the patient who are going to take laparoscopic surgery at gynecology
Key exclusion criteria	the patient who do not consent with this study the patient who has dementia to take pain scale the patient who has allergic to local analgesia the patient who has allergic to opioid the patient who judged other chief physicians to be inappropriate about the study concerned
Target sample size	100

Research contact person
Name of lead principal investigator	kazuo ando
Organization	aichi medical university hospital
Division name	anesthesiology
Address	karimata1-1 yazako nagakute aichi
TEL	0561623311
Email	ando_kazuo0210@hotmail.com

Public contact
Name of contact person	kazuo ando
Organization	aichi medical university hospital
Division name	anesthesiology
Address	karimata1-1 yazako nagakute aichi
TEL	0561623311
Homepage URL
Email	ando_kazuo0210@hotmail.com

Sponsor
Institute	aichi medical university hospital
Institute
Department

Funding Source
Organization	aichi medical university 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	2014 Year 05 Month 12 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 12 Day
Anticipated trial start date	2014 Year 05 Month 12 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	2014 Year 05 Month 12 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016243