Infiltration Analgesia After Caesarean Section
Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial
Infiltration of a local anesthetic into the surgical wound is a simple method to strive to control postoperative pain after surgery. In the investigators institution, this method is used quite often. However, there is a controversy regarding the analgesic efficacy. Moreover, the cost of the single use elastomeric pump used with this procedure is clearly higher than the costs of other routinely used analgesic methods.
According to the investigators observations, infiltration of a local anesthetic into the surgical wound after caesarean section seems to reduce the need for rescue analgesics. However, the scientific evidence of the efficacy of this technique is weak. The investigators decided to conduct a prospective, controlled, randomised, double blind trial on this topic.
The hypothesis is that wound infiltration with local anesthetic will reduce postoperative pain and opioid consumption after caesarean section without major adverse effects.
研究概览
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
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-
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Joensuu、芬兰、80880
- North Karelia Central Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- volunteer
- age over 18 years
- spinal anesthesia
- ASA 1-2
- no allergy to used medications
- no medications which have effect on pain perception
Exclusion Criteria:
- patient's refusal to participate
- marked systemic disease
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Ropivacaine 0,75%
Postoperative wound infusion 15 mg /h / 48h
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Postoperative wound infusion 2 ml/ h/ 48h
|
|
安慰剂比较：NaCl 0,9%
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
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Postoperative wound infusion 2 ml/h/48h
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The Demand of Rescue Analgesics (Oxycodone)
大体时间：48 hours
|
The amount of oxycodone required 48 hours after operation.
Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.
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48 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Strength of Pain on Numerical Rating Scale (NRS)
大体时间：48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)
|
Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.
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48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)
|
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Postoperative Nausea and Vomiting (PONV)
大体时间：48 hours
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The numbers of patients with at least mild nausea at any time post-operatively.
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48 hours
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合作者和调查者
调查人员
- 首席研究员：Sakari Syväoja, MD、North Carelia CH, Department of Anesthesia
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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