Local Infiltration Analgesia After Abdominal Hysterectomy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total morphine consumption
研究概览
简要总结
The aim of the study is to evaluate traditional analgesic therapy after abdominal hysterectomy with single infiltration of local anesthetics in the surgical area at the end of surgery.
详细描述
The study is a controlled, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden. The injectant mixture consists of 300 mg ropivacaine mixed with 30 mg ketorolac and 0.5 mg epinephrine. Total volume of the solution is 156 ml. The normal saline injection is used in the control group in the same manner as in the LIA group. The parameters which would be evaluated are consumption of morphine, pain intensity and side effects.
The primary objective is to evaluate whether local infiltration analgesia (LIA) into the operating field will reduce morphine consumption during the first 24 postoperative hours in patients undergoing abdominal hysterectomy (AH).
Secondary end-points are pain intensity, incidence of nausea and vomiting, sedation intensity.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients requiring abdominal hysterectomy
排除标准
- •Body mass index > 35
- •American Society of Anesthesiologists classification > 3
- •Renal dysfunction
- •Allergic to acetylsalicylic acid
- •Unwilling to provide informed consent
研究组 & 干预措施
Group P
Group P (Placebo) receives a local infiltration of saline in the operating field and ketorolac iv.
In Group P the injectant consists of saline, total volume 156 mL. This is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. Ketorolac 30 mg (1 mL) is also injected iv.
干预措施: Placebo (Drug)
Group A
Group A (Active) receives a local infiltration of ropivacaine, ketorolac and epinephrine in the operating field and saline iv.
Drug: ropivacaine, ketorelac and epinephrine
In Group A the injectant mixture consists of ropivacaine 300 mg mixed with 30 mg ketorolac and 0.5 mg epinephrine, total volume 156 mL. This mixture is infiltrated by the surgeon into the soft tissue of the vagina, tubosacral and rotundum ligaments, in the abdominal fascia and subcutaneous at the end of surgery. One mL saline is also injected iv.
干预措施: ropivacaine, ketorelac and epinephrine (Drug)
结局指标
主要结局
Total morphine consumption
时间窗: 0-24 hours postoperatively
次要结局
- Incidence of nausea and vomiting(0-24 hours postoperatively)
- Sedation intensity (Ramsey scale)(0-24 hours postoperatively)
- Pain intensity (NRS, Numeric Rating Score 0-10)(0-24 hours postoperatively)