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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000031883 |
Receipt No. | R000036402 |
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 |
Date of disclosure of the study information | 2018/03/28 |
Last modified on | 2018/03/25 |
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 |
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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 |
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Scientific Title:Acronym | The effect of Sub-Tenon's block as post-operative analgasia of pediatric strabismus surgery. | |
Region |
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Condition | ||||
Condition | strabisumus | |||
Classification by specialty |
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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 |
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Interventions/Control_1 | At the conclusion of surgery, Sub-Tenon's block was performed with 0.75% ropivacaine
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Interventions/Control_2 | At the conclusion of surgery, Sub-Tenon's block was performed with 2% lidocaine
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Interventions/Control_3 | ||
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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.
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Key exclusion criteria | the patients has allergic to local anesthesia
the patients have mental retardation |
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Target sample size | 50 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
okasuke@med.kitasato-u.ac.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
strawberry.shortcake.11055021@hotmail.com |
Sponsor | |
Institute | Kitasato University |
Institute | |
Department |
Funding Source | |
Organization | Kitasato University Hospital |
Organization | |
Division | |
Category of Funding Organization | Other |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Management information | |||||||
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Last modified on |
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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 | |
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Research case data | |
Registered date | File name |