Peritoneal Ropivacaine Infiltration on Postoperative Pain in Children Affected
|ClinicalTrials.gov Identifier: NCT01997593|
Recruitment Status : Completed
First Posted : November 28, 2013
Last Update Posted : March 26, 2015
|Condition or disease||Intervention/treatment||Phase|
|Testicular Colic||Drug: intraperitoneal infiltration of ropivacaine||Phase 2|
- 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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||June 2014|
Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery.
Drug: intraperitoneal infiltration of ropivacaine
intraperitoneal infiltration of ropivacaine by a special equipment
- pain score [ Time Frame: within the first 2days after the surgery ]
- Analgesic dose [ Time Frame: Within the first 2days after the surgery ]
- Gastrointestinal function recovery score [ Time Frame: Within the first 2days after the surgery ]
- Wound score [ Time Frame: Within the first 2days after the surgery ]
- Time to discharge [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01997593
|Wuhan, Hubei, China, 430030|
|Study Director:||Yang Hui, Professor||China Tongji Hospital|