Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

Study Overview
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Brief Summary
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The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.

Detailed Description
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Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources . Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information . Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan

Official Title
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Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery

Conditions
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Testicular, Colic

Intervention / Treatment
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* Drug: intraperitoneal infiltration of ropivacaine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 6 months and 5years. Laparoscopic inguinal hernia repair Laparoscopic testicular descent fixation Exclusion Criteria: Patient who are suffering from mental disease Patient who suffering from neuromuscular disease Local anesthetic allergy Patient who needs directly into ICU after the operation.

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine<br>Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery. | Drug: intraperitoneal infiltration of ropivacaine<br>* intraperitoneal infiltration of ropivacaine by a special equipment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score |  | within the first 2days after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesic dose |  | Within the first 2days after the surgery | 
| Gastrointestinal function recovery score |  | Within the first 2days after the surgery | 
| Wound score |  | Within the first 2days after the surgery | 
| Time to discharge |  | Participants will be followed for the duration of hospital stay, an expected average of 2weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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analgesia, pediatric, pain, laparoscopy, ropivacaine