Local Infiltration Analgesia for Postoperative Pain After Caesarean Section. A Prospective, Randomised, Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- The Demand of Rescue Analgesics (Oxycodone)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •volunteer
- •age over 18 years
- •spinal anesthesia
- •no allergy to used medications
- •no medications which have effect on pain perception
排除标准
- •patient's refusal to participate
- •marked systemic disease
研究组 & 干预措施
Ropivacaine 0,75%
Postoperative wound infusion 15 mg /h / 48h
干预措施: Ropivacaine 0,75% (Drug)
NaCl 0,9%
Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h
干预措施: NaCl 0,9% (Drug)
结局指标
主要结局
The Demand of Rescue Analgesics (Oxycodone)
时间窗: 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.
次要结局
- Strength of Pain on Numerical Rating Scale (NRS)(48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h))
- Postoperative Nausea and Vomiting (PONV)(48 hours)
研究者
Sanna Kouhia
MD
North Karelia Central Hospital