UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	postoperative analgesic effect between rectus shesth block and local anethetics infiltration
Title of the study (Brief title)	postoperatibve analgesic effect in chils's hernia operation
Region	Japan

Condition
Condition	inguinal hernia
Classification by specialty	Surgery in general Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	we study postoperative analgesia between rectus sheath block and local anesthetic infiltration in child's inguinal hernia.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Face and FLACC scale
Key secondary outcomes	Evaluation of post operative chronic pain

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	rectus sheath block group
Interventions/Control_2	local anesthetic infiltration group
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	2 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	1 port laparoscopic inguinal hernia operation in child
Key exclusion criteria	asa ps overthree central or pheriferal nerve neuropathy coagulopathy heart liver and renal disease sever dm allergy for ropivacaine the case that anesthesiologist judged inappropriate
Target sample size	80

Research contact person
Name of lead principal investigator	Takahiro Tamura
Organization	Japanease red cross nagoya daiichi hospital
Division name	Department of anesthesia
Address	35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL	052-481-5111
Email	takahiro@nagoya-1st.jrc.or.jp

Public contact
Name of contact person	Takahiro Tamura
Organization	Japanease red cross nagoya daiichi hospital
Division name	Department of anesthesia
Address	35, Michisita-cho 3, Nakamura-ku, Nagoya city, Aichi, Japan
TEL	052-481-5111
Homepage URL
Email	takahiro@nagoya-1st.jrc.or.jp

Sponsor
Institute	Nagoya university graduste school of medicine
Institute
Department

Funding Source
Organization	Nagoya university graduste school of medicine
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 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 07 Month 14 Day
Anticipated trial start date	2015 Year 07 Month 14 Day
Last follow-up date	2017 Year 02 Month 13 Day
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 06 Month 16 Day
Last modified on	2017 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020771