UMIN-CTR Clinical Trial

Basic information
Public title	The effect of Sub-Tenon's block as post-operative analgesia of pediatric strabismus surgery. A comparison of 2% Lidocaine and 0.75% Ropivacaine
Acronym	The effect of Sub-Tenon's block as post-operative analgasia of pediatric strabismus surgery.
Scientific Title	The effect of Sub-Tenon's block as post-operative analgesia of pediatric strabismus surgery. A comparison of 2% Lidocaine and 0.75% Ropivacaine
Scientific Title:Acronym	The effect of Sub-Tenon's block as post-operative analgasia of pediatric strabismus surgery.
Region	Japan

Condition
Condition	strabisumus
Classification by specialty	Ophthalmology Anesthesiology Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	It is known that pediatric strabisumus surgery is accompanied by strong post-operative pain which causes the distress and abnormal behavior and also delayed discharge. Although Sub-Tenon's block is normally used as regional anesthesia for adult, It is reported that Sub-Tenon's block is also useful as post-operative analgesia of pediatric strabismus surgery under general anesthesia. But there is no report which shows that the effect of Sub-Tenon's block is depending of the kind of the local anesthetic. we compared the post-operative pain after Sub-Tenon's block with 0.75% ropivacaine and 2% lidocaine at the conclusion of the operation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We measured the pain scale with using face scale at immediately after the surgery, 3hours later, 6hours later, at dinner and discharge. We assessed the number of times of taking pain killers, feeling nausea and vomiting until discharge.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	At the conclusion of surgery, Sub-Tenon's block was performed with 0.75% ropivacaine
Interventions/Control_2	At the conclusion of surgery, Sub-Tenon's block was performed with 2% lidocaine
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	5 years-old <=
Age-upper limit	15 years-old >=
Gender	Male and Female
Key inclusion criteria	The study group included the patients who were scheduled for unilateral/bilateral strabisumus surgery. Ages ranged from 5 years old to 15 years old.
Key exclusion criteria	the patients has allergic to local anesthesia the patients have mental retardation
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Hirotsugu Okamoto
Organization	Kitasato University Hospital
Division name	Department of Anesthesiology
Zip code
Address	1-15-1 kitasato minami ward sagamihara, Kanagawa Japan
TEL	042-778-8111
Email	okasuke@med.kitasato-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Ayano Nakazawa
Organization	Kitasato University Hospital
Division name	Department of Anesthesiology
Zip code
Address	1-15-1 kitasato minami ward sagamihara, Kanagawa 252-0373 Japan
TEL	042-778-8111
Homepage URL
Email	strawberry.shortcake.11055021@hotmail.com

Sponsor
Institute	Kitasato University
Institute
Department

Funding Source
Organization	Kitasato University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 03 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 03 Month 28 Day
Date of IRB
Anticipated trial start date	2018 Year 03 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 25 Day
Last modified on	2018 Year 03 Month 25 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036402

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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