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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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7 April 2015 |
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Main ID: |
NCT01997593 |
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Date of registration:
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27/10/2013 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
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Scientific title:
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Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery |
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Date of first enrolment:
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November 2013 |
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Target sample size:
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70 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01997593 |
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Study type:
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Interventional |
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Study design:
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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China
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Contacts
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Name:
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Yang Hui, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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China Tongji Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Between 6 months and 5years.
2. Laparoscopic inguinal hernia repair
3. Laparoscopic testicular descent fixation
Exclusion Criteria:
1. Patient who are suffering from mental disease
2. Patient who suffering from neuromuscular disease
3. Local anesthetic allergy
4. Patient who needs directly into ICU after the operation.
Age minimum:
6 Months
Age maximum:
5 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Testicular
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Colic
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Intervention(s)
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Drug: intraperitoneal infiltration of ropivacaine
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Primary Outcome(s)
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pain score
[Time Frame: within the first 2days after the surgery]
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Secondary Outcome(s)
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Analgesic dose
[Time Frame: Within the first 2days after the surgery]
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Time to discharge
[Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks]
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Gastrointestinal function recovery score
[Time Frame: Within the first 2days after the surgery]
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Wound score
[Time Frame: Within the first 2days after the surgery]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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