NCT01997593已完成2 期
Evaluate the Analgesic Effect of Intraperitoneal Infiltration of Ropivacaine in Children Undergoing Laparoscopic Surgery
Ping Yang1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- pain score
研究概览
简要总结
The aim of this study was to evaluate the analgesic effect of intraperitoneal infiltration of ropivacaine in children undergoing laparoscopic surgery.
详细描述
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Months 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 months and 5years.
- •Laparoscopic inguinal hernia repair
- •Laparoscopic testicular descent fixation
排除标准
- •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.
研究组 & 干预措施
ropivacaine
Experimental
Preincisional wound intraperitoneal infiltration of 1% ropivacaine 0.3ml/kg was performed in group I patients before surgery.
干预措施: intraperitoneal infiltration of ropivacaine (Drug)
结局指标
主要结局
pain score
时间窗: within the first 2days after the surgery
次要结局
- Time to discharge(Participants will be followed for the duration of hospital stay, an expected average of 2weeks)
- Gastrointestinal function recovery score(Within the first 2days after the surgery)
- Analgesic dose(Within the first 2days after the surgery)
- Wound score(Within the first 2days after the surgery)
研究者
Ping Yang
Principal Investigator
Tongji Hospital
研究点 (1)
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