Postoperative Analgesia After Total Knee Arthroplasty. A Comparison of Continuous Epidural Infusion and Wound Infiltration With Continuous Intraarticular Infusion
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Analgésia consumption
研究概览
简要总结
Total knee arthroplasty (TKA) is associated with moderate to severe postoperative pain. Although epidural treatment provides good and reliable postoperative pain relief after THA, it may cause urinary retention, nausea, hypotension, diminished muscle control, and delayed mobilization.
The challenge of new analgesic regimes is to reduce the occurrence of side effects while maintaining adequate pain relief and maximum muscle control. A relatively new method to provide postoperative pain relief after TKA is local infiltration analgesia combined with single-shot injection(s) or continuous infusion of local anesthetics into the surgical site. As local infiltration analgesia combined with continuous intraarticular infusion compared with continuous epidural infusion has not been evaluated, our study was designed to determine whether this technique could enhance analgesia and improve patient outcome after TKA. This study compares continuous epidural infusion of Ropivacaine and intravenous Ketorolac with local infiltration analgesia with Ropivacaine, Ketorolac and Adrenaline combined with continuous intraarticular infusion of Ropivacaine and Ketorolac.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted consecutively to primary total knee arthroplasty.
- •Provided informed consent
排除标准
- •Fertile women with positive pregnancy test, nursing mothers, fertile women who do not use safe contraception
- •Severe chronic neurogenic pain
- •Medical treated diabetes
- •Contraindications for spinal aesthesia and epidural analgesia
- •Known hypersensitivity towards study drugs
- •Rheumatoid arthritis
- •Treatment with narcotics
- •Treatment with antidepressants
- •Severe obesity BMI>35
- •Treatment with antacid
- •Not able to speak and understand Danish
研究组 & 干预措施
1
干预措施: Ropivacaine, Ketorolac, adrenaline (Drug)
2
干预措施: Ropivacaine Ketorolac (Drug)
结局指标
主要结局
Analgésia consumption
时间窗: 48 h
次要结局
- Time to discharge
- Cytokine level(48 h)
- Pain scores VAS(72 h)
- Side-effects(72 h)
