UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Analgesia
Title of the study (Brief title)	A Comparison Examination between Transverse Abdominal Plane Block and Rectus Sheath Block in Terms of Postoperative Alalgesia
Region	Japan

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

Objectives
Narrative objectives1	to compare transverse abdominal plane block and rectus sheath block in terms of effectiveness for postoperative analgesia after gynecologic laparoscopic surgery
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	visual analog scale scores recorded at 2,6,12 amd 24h after surgery
Key secondary outcomes	frequency of analgesic used after surgery

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants 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	Ultrasound guided transverse abdominal plane block
Interventions/Control_2	Ultrasound guided rectus sheath 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	70 years-old >=
Gender	Female
Key inclusion criteria	1)Scheduled operation of gynecologic laparoscopic surgery 2)Written informed concent
Key exclusion criteria	1)Emergency surgery 2)Abdominal surgery 3)Allergy of study medicine
Target sample size	50

Research contact person
Name of lead principal investigator	Yusuke Shimakawa
Organization	Saga-Ken medical centre koseikan
Division name	anesthesiology
Address	400, Nakabaru,Kase,Saga,Japan
TEL	0952242171
Email	shimakawa-y@koseikan.jp

Public contact
Name of contact person	Yusuke Shimakawa
Organization	Saga-Ken medical centre koseikan
Division name	anesthesiology
Address	400,Nakabaru,Kase,Saga,Japam
TEL	0952242171
Homepage URL
Email	shimakawa-y@koseikan.jp

Sponsor
Institute	Saga-Ken medical centre koseikan
Institute
Department

Funding Source
Organization	Saga-Ken medical centre koseikan
Organization
Division
Category of Funding Organization	Local Government
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 06 Month 15 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 06 Month 14 Day
Anticipated trial start date	2016 Year 06 Month 15 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	2016 Year 06 Month 14 Day
Last modified on	2016 Year 09 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026183