Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT01997593
Status:
COMPLETED
Last Update Posted:
2015-03-26
First Post:
2013-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
Sponsor:
Ping Yang
Organization:
Study Overview
Official Title:
Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: