Evaluation of Dexketoprofen Given Intravenous or Intrathecal in Postoperative Pain in Patients Undergoing Total Knee Arthroplasty
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- VAS Score in 8hours after surgery
研究概览
简要总结
Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.
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
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral total knee arthroplasty
- •accept to enter the study
- •ASA score I or II
- •hospitalization for at least 2 days
排除标准
- •allergy in any given medications
- •active gastrointestinal bleeding or other active bleeding
- •history of peptic ulcer
- •renal failure
- •hepatic failure
- •chronic heart failure
研究组 & 干预措施
Group IV
Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.
干预措施: Dexketoprofen Trometamol (Drug)
Group IV
Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.
干预措施: Ropivacaine Hydrochloride 7.5 MG/ML (Drug)
Group Periarticular
Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.
干预措施: Dexketoprofen Trometamol (Drug)
Group Periarticular
Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.
干预措施: Ropivacaine Hydrochloride 7.5 MG/ML (Drug)
Group P
Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.
干预措施: Ropivacaine Hydrochloride 7.5 MG/ML (Drug)
结局指标
主要结局
VAS Score in 8hours after surgery
时间窗: 8h
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points. 10 describes the worst pain that a person ever imagined.
Total tramadol consumption the first 24hours
时间窗: 24h
VAS Score 24hours after surgery
时间窗: 24h
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
VAS Score 48hours after surgery
时间窗: 48h
The visual analogue scale or visual analog scale (VAS) is a psychometric response scale which can be used in questionnaires. It is a measurement instrument for subjective characteristics or attitudes that cannot be directly measured. When responding to a VAS item, respondents specify their level of agreement to a statement by indicating a position along a continuous line between two end-points.
次要结局
未报告次要终点
研究者
Elena Nikolakopoulou
Principal Investigator
KAT General Hospital