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临床试验/NCT02630160
NCT02630160已完成4 期

The Influence of Local Infiltration Analgesia by Catheter in Postoperative Control Pain After Total Hip Replacement

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Intraarticular infusion with Bupivacaine Hydrochloride

干预措施: Bupivacaine hydrochloride (Drug)

Intraarticular Physiological Saline

Placebo Comparator

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

Active Comparator

Perifascial infusion with Bupivacaine Hydrochloride

干预措施: Bupivacaine hydrochloride (Drug)

Perifascial Physiological Saline

Placebo Comparator

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

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Daniel Pérez Prieto

MD

Parc de Salut Mar

研究点 (1)

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