Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
This study is not yet open for participant recruitment.
Verified November 2013 by Tongji Hospital
Information provided by (Responsible Party):
Ping Yang, Tongji Hospital
First received: October 27, 2013
Last updated: November 29, 2013
Last verified: November 2013
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.
Drug: intraperitoneal infiltration of ropivacaine
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery|
Resource links provided by NLM:
Further study details as provided by Tongji Hospital:
Primary Outcome Measures:
- pain score [ Time Frame: within the first 2days after the surgery ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Analgesic dose [ Time Frame: Within the first 2days after the surgery ] [ Designated as safety issue: No ]
- Gastrointestinal function recovery score [ Time Frame: Within the first 2days after the surgery ] [ Designated as safety issue: No ]
- Wound score [ Time Frame: Within the first 2days after the surgery ] [ Designated as safety issue: No ]
- Time to discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks ] [ Designated as safety issue: No ]
|Study Start Date:||December 2013|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Preincisional wound intraperitoneal infiltration of 0.5% ropivacaine 0.25ml/kg was performed in group I patients before surgery.
|Drug: intraperitoneal infiltration of ropivacaine|
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01997593
|Tongji Hospital||Not yet recruiting|
|Wuhan, Hubei, China, 430030|
|Contact: Yang ping, master 8613419518289 firstname.lastname@example.org|
|Principal Investigator: Yang ping, Master|
Sponsors and Collaborators
|Study Director:||Yang Hui, Professor||China Tongji Hospital|