Intraoperative Wound Infiltration With Local Anaesthetic in Surgical Patients; Is There Any Late Effect on the Postoperative Pain and the Requirements of Analgesia ? A Randomized Control Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Intensity of postoperative pain
研究概览
简要总结
Background: Intraoperative wound infiltration with local anaesthetic is commonly used. Apart from the obvious immediate action it has been supported that a possible down regulation of pain receptors may lead to longer effects. Our aim was to compare the use of local anaesthetic versus placebo in order to assess if indeed there is a late beneficial effect.
Materials and methods: We will conduct a RCT involving 400 consecutive general surgery patients randomized in 2 groups: Group A= placebo, Group B= wound infiltration with ropivacaine 10%. We will record the preoperative and postoperative pain for the 1st week as well as the type and quantity of the analgesia used during the study period.
Hypothesis : patients who receive intraoperatively wound infiltration with local anaesthetic have lower pain during the 1st postoperative week and require less pain killers .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with conditions that require surgery ( general surgery)
- •Must be able to comprehent the questions , fill documents, communicate well with the doctors
- •Patients who will have at least one surgical incision under general or regional anaesthesia
排除标准
- •Patients who could not comprehend well
- •patients who remained intubated even for one postoperative day
- •Patients who were discharged the day of the operation
研究组 & 干预措施
intervetional group (local anaesthetic)
intraoperative wound infiltration with ropivacaine 10%.
干预措施: Wound infiltration with local anaesthetic (Procedure)
intervetional group (local anaesthetic)
intraoperative wound infiltration with ropivacaine 10%.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Intensity of postoperative pain
时间窗: six days
the intensity of the pain will be assessed using the : The visual analogue scale (VAS) which is a psychometric response scale and the patient has to indicate a position along a continuous line between two end-points (no pain and maximum pain) and (2) the numeric rating scale (NRS) which is a segmented numeric version of the visual analog scale (VAS) in which the patient indicates the number (0-10) that best reflects the intensity of their pain. Both tests are easy to obtain, reliable, valid and can detect changes of over time
次要结局
- Quantity and quality of the required postoperative analgesia(six days)
研究者
Sophocles Lanitis
Dr. Sophocles Lanitis, M.D, PhD
Hellenic Red Cross Hospital