The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in pain measured with a visual analog scale
研究概览
简要总结
A randomized double-blind clinical trial was performed. There were 4 groups according to catheter placement and infusion constituents: 1) Intraarticular catheter + anesthetics; 2) Intraarticular catheter +placebo; 3) Subfascial catheter + anesthetics; 4) Subfascial catheter + placebo. The anesthetics infusion contained bupivacaine (bolus + continuous perfusion up to 36 hours). The placebo solution consisted in physiological serum (bolus + continuous perfusion up to 36 hours). Randomization was performed in the hospital pharmacy and the surgeon kept out the surgical field when the resident placed the catheter. The same conventional analgesic schedule was prescribed to all patients: PCA (patient controlled analgesia) + paracetamol 1g/6h + dexketoprofen 50mg/12h. The pain was evaluated by means of PCA (patient controlled analgesia) shots and the VAS (visual analog scale). Side effects, time to start rehabilitation and time to discharge were also analyzed. A statistical analysis was performed to compare all this variables between the 4 groups (SPSS 18.0).
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
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary total Hip Replacement
排除标准
- •Allergic to Bupivacaine
研究组 & 干预措施
Intraarticular Catheter with anesthesic
Intraarticular infusion with Bupivacaine Hydrochloride
干预措施: Bupivacaine hydrochloride (Drug)
Intraarticular Physiological Saline
Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by intraarticular catheter
干预措施: Physiological Saline (Other)
Perifascial Catheter with anesthesic
Perifascial infusion with Bupivacaine Hydrochloride
干预措施: Bupivacaine hydrochloride (Drug)
Perifascial Physiological Saline
Infusion of Physiological Saline [Flebobag Salina Fisiologica Grifols 0.9%] Sterile Solution by Perifascial catheter
干预措施: Physiological Saline (Other)
结局指标
主要结局
Change in pain measured with a visual analog scale
时间窗: 36 hours
Visual analog pain scale score every eight hours for 36 hours postoperatively
次要结局
未报告次要终点
研究者
Daniel Pérez Prieto
MD
Parc de Salut Mar
