UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficiency and safety of laparoscopic regional anesthesia for abdominal wall in gynecologic laparoscopy: a randomized trial
Title of the study (Brief title)	Efficiency and safety of laparoscopic reutus shaeth block
Region	Japan

Condition
Condition	Regional anesthesia in gynecologic laparoscopy
Classification by specialty	Surgery in general Obsterics and gynecology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Our aim is to evaluate the efficiency and the safety of laparoscopic regional anesthesia for abdominal wall in laparoscopy.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Evaluating postoperative pain at 6 hour, 12hour and postoperative days1-3 by Wong-Baker pain scale .
Key secondary outcomes	Evaluating the number of postoperative analgesics.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Numbered container method

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	Patients randomly are assigned with a 1:1 ratio to receive injection or not. Control group have no regional anesthesia and prescribe oral medicine, suppository and intramuscular injection of analgesics.
Interventions/Control_2	Patients randomly are assigned with a 1:1 ratio to receive injection or not. Injection group are injected regional anesthetic onto peritoneum in laparoscopy under general anesthesia. This group can also receive analgesics.
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	Not applicable
Gender	Female
Key inclusion criteria	1)Patients scheduling to undergo benign gynecologic laparoscopy 2)Female patients older than 19 years 3)Patients who approve our research program and write informed consent
Key exclusion criteria	1)Patients weighing less than 50kg 2)Patients with severe disorder of liver function 3)Patients on chronic hemodialysis 4)Patients with clotting abnormality 5)Patients taking anticoagulant and antiplatelet 6)Patients with diabetes mellitus and multiple sclerosis 7)Patients with allergy for regional anesthetic 8)Patients scheduling to undergo single-incision laparoscopy 9)Patients with any difficulty in regional anesthesia
Target sample size	200

Research contact person
Name of lead principal investigator	Toru Hachisuga
Organization	University of Occupational Environmental Health, Japan
Division name	Department of Obstetrics and Gynecology
Address	1-1 Iseigaoka, Yahata-Nishi-Ku, Kitakyushu, Fukuoka, Japan
TEL	093-603-1611
Email	thachisu@med.uoeh-u.ac.jp

Public contact
Name of contact person	Yasuyuki Kinjo
Organization	University of Occupational Environmental Health, Japan
Division name	Department of Obstetrics and Gynecology
Address	1-1 Iseigaoka, Yahata-Nishi-Ku, Kitakyushu, Fukuoka, Japan
TEL	093-603-1611
Homepage URL
Email	kinjo-yasuyuki@med.uoeh-u.ac.jp

Sponsor
Institute	Department of Obstetrics and Gynecology, University of Occupational Environmental Health, Japan
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
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	産業医科大学病院（福岡県）

Other administrative information
Date of disclosure of the study information	2014 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 07 Month 13 Day
Anticipated trial start date	2014 Year 08 Month 01 Day
Last follow-up date	2017 Year 02 Month 20 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 02 Month 20 Day
Date analysis concluded	2017 Year 02 Month 20 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 01 Day
Last modified on	2017 Year 02 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016945