Effect of Local Infiltration Anesthesia With Ropivacaine on Postoperative Pain After Hip Hemiarthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Pain sensation during mobilization in the post-anesthesia care unit.
研究概览
简要总结
At St.Olavs Hospital each year about 400 patients are treated for femoral neck fractures, 250 of them receiving hemiarthroplasty. Implementation of fast-track clinical pathways reduces morbidity and enhances recovery of patients undergoing hemiarthroplasty. One of the key prerequisites for early rehabilitation is optimized pain relief. Local infiltration anesthesia with Ropivacaine is part of a multimodal pain regimen for patients receiving hemiarthroplasty at St.Olavs Hospital, although the pain reducing effect of local Ropivacaine after hemiarthroplasty has not been investigated in clinical trials. In this study it will be investigated whether a single shot with Ropivacaine reduces acute postoperative pain and opioid requirement after hemiarthroplasty. The findings of this study will have a direct impact on patient treatment.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for hemiarthroplasty at St. Olavs Hospital
- •competent and willing to give consent
- •able to be mobilized in the PACU and in the trauma ward unit.
排除标准
- •contraindications for spinal anesthesia, Dexamethasone, Dolcontin or Acetaminophene
- •receiving general anesthesia
- •patients operated on with an approach different to standard direct lateral surgery
- •receiving osteosyntheses
- •receiving femoral block less than 4 hours before surgery
研究组 & 干预措施
Ropivacaine
Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)
干预措施: Ropivacaine (Drug)
Ropivacaine
Local infiltration anesthesia, single shot during surgery. 150 ml Ropivacaine (2mg/ml), added 0.5 ml Epinephrine (1mg/ml)
干预措施: Epinephrine (Drug)
Placebo
Single shot during surgery.150 ml saline
干预措施: Saline (Drug)
结局指标
主要结局
Pain sensation during mobilization in the post-anesthesia care unit.
时间窗: 24 hours (day of surgery)
Pain is registered using the numeric rating scale (NRS) by the nurses both during rest and mobilization. The patients are asked a standard question; on a scale from 0 to 10, where 0 is no pain and 10 is the worst imaginable pain, can you define the pain you have right now?
次要结局
- Total consumption of opioids on the first postoperative day(48 hrs (first postoperative day))
- Pain during mobilization on the day after surgery(48 hours (first postoperative day))