NCT01997593

Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Ping Yang · Academic / Other
• Sex: All
• Age: 6 Months – 5 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

1. Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing. 2. Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. 3. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources . 4. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information . 5. 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. 6. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. 7. 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 8. 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

Conditions

• Testicular
• Colic

Interventions

Type	Name	Description
DRUG	intraperitoneal infiltration of ropivacaine	intraperitoneal infiltration of ropivacaine by a special equipment

Timeline

• Start date: 2013-11-01
• Primary completion: 2014-05-01
• Completion: 2014-06-01
• First posted: 2013-11-28
• Last updated: 2015-03-26

Locations

1 site across 1 country: China